Noah Medical
Overview
Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members. Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery.
About The Team The Quality team is an integral part of ensuring products, services, and processes are of the highest quality and meet customer and regulatory requirements. We are a team of detail-oriented professionals who take pride in meticulously assessing processes, products, and services to identify and rectify issues, ensuring the utmost quality and customer satisfaction. If you share our passion for maintaining the highest standards of quality and are dedicated to making a positive impact, we invite you to consider joining our Quality Assurance Team. Together, we can continue to elevate our organizations quality standards and provide unparalleled value to our customers and stakeholders.
A Day In The Life Of Our Manager, Complaints and Post-Market
Perform a wide variety of activities to ensure compliance with applicable quality and regulatory requirements.
Oversee day-to-day activities of the complaint handling team, ensuring complaints are handled promptly and accurately
Work closely with Product Quality Engineering team to ensure that investigations and complaints are completed and closed out in a timely manner
Review complaint files to ensure all complaint elements have been addressed and properly documented within the complaint file
Manage adverse event reporting activities including decision rationale and reporting documentation.
Submit adverse event reports to regulatory authorities
Manage complaint metrics and analytics including trending and measure against statistical trend limits
Schedule post market surveillance reviews and complete post market surveillance reports based on applicable regulatory requirements
Coordinate with clinical, marketing, sales, regulatory, and R&D to obtain their respective post market surveillance information based on regulatory requirements
Initiate risk file updates based on post market data such as complaint rates and new hazards
Review customer inquiries and service reports for potential complaints
Identify and escalate complaints for potential adverse event reporting decisions
Perform complaint case final reviews for closure
Manage complaint handling team activities and provide guidance as needed
Review, revise and create SOPs (Standard Operating Procedures) and/or WIs(Work Instructions) related to complaint handling, adverse event reporting
Prepare SOPs and WIs and gather data as needed to support ISO 13485:2016 clause 8.2.1 Feedback and for OUS regulatory requirements
Assist in audits (internal and external). May also conduct internal audits as needed.
Other QMS activities as assigned
About You
At minimum a BS degree in a technical field such as engineering, computer science, or a science related discipline.
5+ years of complaint-handling experience in the medical device industry.
Ability to manage others, their work, and your own multiple competing priorities.
Working knowledge of the entire complaint handling process from intake, investigation, closure, and reportability assessments.
Strong working knowledge of US FDA 21 CFR 820.198, 803, and 806 requirements.
Basic working knowledge of OUS adverse event reporting requirements.
Basic working knowledge of OUS post market surveillance requirements.
Working statistical knowledge as it pertains to trending and an intermediate understanding of mechanical and software aspects of medical devices.
Pay Transparency The Pay Range for this position is listed. Noah Medical offers a comprehensive benefits package including: competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office work schedules. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors such as location as permitted by law. Total compensation may also include additional forms of incentives.
$120,000 - $172,000 USD
Benefits & Perks (For Full Time Employees)
Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options
Equity & Bonus Program
Life Insurance (company paid & supplemental) and Disability insurance
Mental health support through medical insurance programs
Legal and Pet Insurance
12+ paid holidays, 15-20 days of PTO + sick time
Paid parental leave
In-office snacks and beverages
Learning & Development Opportunities: On-demand online training and book reimbursement
Team building and company organized social and celebration events
Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable.
Noah Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws.
NO AGENCIES PLEASE - Please do not outreach to any managers or submit any resumes without a signed agreement from Talent Acquisition. Resumes shared with anyone at Noah Medical without a signed agreement will be considered your gift to us and no fee will be paid.
Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.
As set forth in Noah Medicals Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.
If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:
A disabled veteran is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.
A recently separated veteran means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.
An active duty wartime or campaign badge veteran means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
An Armed forces service medal veteran means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.
Select…
Voluntary Self-Identification of Disability Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026
Why are you being asked to complete this form?
We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.
Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor0s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp .
How do you know if you have a disability?
A disability is a condition that substantially limits one or more of your major life activities. If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:
Alcohol or other substance use disorder (not currently using drugs illegally)
Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
Blind or low vision
Cancer (past or present)
Cardiovascular or heart disease
Celiac disease
Cerebral palsy
Deaf or serious difficulty hearing
Diabetes
Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
Epilepsy or other seizure disorder
Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
Intellectual or developmental disability
Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
Missing limbs or partially missing limbs
Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
Nervous system condition, for example, migraine headaches, Parkinsons disease, multiple sclerosis (MS)
Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
Partial or complete paralysis (any cause)
Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
Short stature (dwarfism)
Traumatic brain injury
Disability Status Select…
PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
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About The Team The Quality team is an integral part of ensuring products, services, and processes are of the highest quality and meet customer and regulatory requirements. We are a team of detail-oriented professionals who take pride in meticulously assessing processes, products, and services to identify and rectify issues, ensuring the utmost quality and customer satisfaction. If you share our passion for maintaining the highest standards of quality and are dedicated to making a positive impact, we invite you to consider joining our Quality Assurance Team. Together, we can continue to elevate our organizations quality standards and provide unparalleled value to our customers and stakeholders.
A Day In The Life Of Our Manager, Complaints and Post-Market
Perform a wide variety of activities to ensure compliance with applicable quality and regulatory requirements.
Oversee day-to-day activities of the complaint handling team, ensuring complaints are handled promptly and accurately
Work closely with Product Quality Engineering team to ensure that investigations and complaints are completed and closed out in a timely manner
Review complaint files to ensure all complaint elements have been addressed and properly documented within the complaint file
Manage adverse event reporting activities including decision rationale and reporting documentation.
Submit adverse event reports to regulatory authorities
Manage complaint metrics and analytics including trending and measure against statistical trend limits
Schedule post market surveillance reviews and complete post market surveillance reports based on applicable regulatory requirements
Coordinate with clinical, marketing, sales, regulatory, and R&D to obtain their respective post market surveillance information based on regulatory requirements
Initiate risk file updates based on post market data such as complaint rates and new hazards
Review customer inquiries and service reports for potential complaints
Identify and escalate complaints for potential adverse event reporting decisions
Perform complaint case final reviews for closure
Manage complaint handling team activities and provide guidance as needed
Review, revise and create SOPs (Standard Operating Procedures) and/or WIs(Work Instructions) related to complaint handling, adverse event reporting
Prepare SOPs and WIs and gather data as needed to support ISO 13485:2016 clause 8.2.1 Feedback and for OUS regulatory requirements
Assist in audits (internal and external). May also conduct internal audits as needed.
Other QMS activities as assigned
About You
At minimum a BS degree in a technical field such as engineering, computer science, or a science related discipline.
5+ years of complaint-handling experience in the medical device industry.
Ability to manage others, their work, and your own multiple competing priorities.
Working knowledge of the entire complaint handling process from intake, investigation, closure, and reportability assessments.
Strong working knowledge of US FDA 21 CFR 820.198, 803, and 806 requirements.
Basic working knowledge of OUS adverse event reporting requirements.
Basic working knowledge of OUS post market surveillance requirements.
Working statistical knowledge as it pertains to trending and an intermediate understanding of mechanical and software aspects of medical devices.
Pay Transparency The Pay Range for this position is listed. Noah Medical offers a comprehensive benefits package including: competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office work schedules. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors such as location as permitted by law. Total compensation may also include additional forms of incentives.
$120,000 - $172,000 USD
Benefits & Perks (For Full Time Employees)
Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options
Equity & Bonus Program
Life Insurance (company paid & supplemental) and Disability insurance
Mental health support through medical insurance programs
Legal and Pet Insurance
12+ paid holidays, 15-20 days of PTO + sick time
Paid parental leave
In-office snacks and beverages
Learning & Development Opportunities: On-demand online training and book reimbursement
Team building and company organized social and celebration events
Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable.
Noah Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws.
NO AGENCIES PLEASE - Please do not outreach to any managers or submit any resumes without a signed agreement from Talent Acquisition. Resumes shared with anyone at Noah Medical without a signed agreement will be considered your gift to us and no fee will be paid.
Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.
As set forth in Noah Medicals Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.
If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:
A disabled veteran is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.
A recently separated veteran means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.
An active duty wartime or campaign badge veteran means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
An Armed forces service medal veteran means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.
Select…
Voluntary Self-Identification of Disability Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026
Why are you being asked to complete this form?
We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.
Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor0s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp .
How do you know if you have a disability?
A disability is a condition that substantially limits one or more of your major life activities. If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:
Alcohol or other substance use disorder (not currently using drugs illegally)
Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
Blind or low vision
Cancer (past or present)
Cardiovascular or heart disease
Celiac disease
Cerebral palsy
Deaf or serious difficulty hearing
Diabetes
Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
Epilepsy or other seizure disorder
Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
Intellectual or developmental disability
Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
Missing limbs or partially missing limbs
Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
Nervous system condition, for example, migraine headaches, Parkinsons disease, multiple sclerosis (MS)
Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
Partial or complete paralysis (any cause)
Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
Short stature (dwarfism)
Traumatic brain injury
Disability Status Select…
PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
#J-18808-Ljbffr