Lexington Medical, Inc.
Quality Engineering Manager New Bedford, MA
Lexington Medical, Inc., Oklahoma City, Oklahoma, United States
Lexington Medical is a medical device company, developing and manufacturing minimally invasive surgical stapling solutions in the Boston area. With the highest standards in design engineering and smart manufacturing, our team delivers disruptive technology to health care providers which improves surgical outcomes for their patients in a thriving $6B+ Surgical Stapler market.
Rooted in a talent dense culture, we are committed to innovation, foster continuous growth and achieve great heights, together. At Lexington Medical, you will have the opportunity to impact the lives of millions of patients worldwide and thrive in a growing company.
Lexington Medical is growing, and we are seeking a Quality Engineering Manager to join our team in Bedford, MA. In this role, you will manage and develop a team of quality engineers while driving design assurance and compliance across the product lifecycle.
Responsibilities :
Manage, mentor, and develop quality engineers, fostering growth, collaboration, and technical excellence.
Lead design quality assurance activities throughout the product lifecycle, from requirements and development through V&V, design transfer, commercialization, and post-market support.
Drive cross-functional collaboration with R&D, Regulatory, Operations, and Manufacturing to ensure quality is embedded at every stage of product development and production.
Provide expertise in Risk Management, Design Verification and Validation, Statistical Methods, Design Controls, and Usability Engineering for both new product introductions and commercially available products.
Review and approve product requirements, test documentation, and design reviews.
Expert interpretation of global medical device regulations and standards (21 CFR 820, EU MDR, ISO 13485, ISO 14971, IEC 60601, IEC 62366, etc.).
Oversee the Corrective and Preventive Action (CAPA) process, ensuring thorough investigation, root cause analysis, implementation, and effectiveness checks.
Support internal audits, external regulatory inspections, and third-party audits.
Oversee post-market surveillance, including trend analysis, risk assessments, and feedback into product improvement.
Responsible for supplier quality audit program.
Partner with quality team to strategically enhance the Quality Management System (QMS) to meet evolving business and regulatory needs.
Qualifications:
Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, or related field.
8+ years of experience leading design quality engineering in the medical device industry, including experience supporting the developing and maintenance of medical devices that have software capabilities.
Proven track record in new product development (NPD/NPI), design transfer, and sustaining engineering.
Strong knowledge of medical device regulations and standards: 21 CFR 820, EU MDR, ISO 13485, ISO 14971, IEC 60601, IEC 62366.
Demonstrated expertise in design controls, risk management, CAPA, complaint handling, and change control.
Experience with sterilization validation, biocompatibility testing, cleanroom practices, or microbiology is a plus.
Skilled in audit preparation and execution for both internal and external inspections.
Strong leadership skills with the ability to influence and collaborate across departments.
CQE certification or equivalent preferred; experience with Arena eQMS a plus.
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* indicates a required field First Name * Last Name * Preferred First Name Email * Phone Resume/CV Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf Education School Select... Degree Select... Select... Select... Start date year End date month Select... End date year LinkedIn Profile Are you authorized to work in the US? * Select... At any time, now or in the future, will you require visa sponsorship to work in the US? * Select... We ask all applicants and offer visa sponsorship for a variety of positions. Are you available to work onsite in Bedford, MA office 5 days a week? * Select... Do you have at least 8 years of quality engineering experience in the medical device industry? * Select... Have you managed or mentored a team of engineers before? * Select... Please select the regulatory standards you have direct experience with (check all that apply): * 21 CFR 820 EU MDR ISO 13485 ISO 14971 IEC 60601 IEC 62366 Do you have hands-on experience with the following? (check all that apply): * Design Controls Verification & Validation (V&V) Usability Engineering Corrective and Preventive Actions (CAPA) Change Control Have you supported new product development and design transfer into manufacturing? Select... Do you have experience supporting medical devices with software components? * Select... 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 hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file. As set forth in Lexington Medical’s 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 measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis 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 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 Labor’s 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, Parkinson’s 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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* indicates a required field First Name * Last Name * Preferred First Name Email * Phone Resume/CV Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf Education School Select... Degree Select... Select... Select... Start date year End date month Select... End date year LinkedIn Profile Are you authorized to work in the US? * Select... At any time, now or in the future, will you require visa sponsorship to work in the US? * Select... We ask all applicants and offer visa sponsorship for a variety of positions. Are you available to work onsite in Bedford, MA office 5 days a week? * Select... Do you have at least 8 years of quality engineering experience in the medical device industry? * Select... Have you managed or mentored a team of engineers before? * Select... Please select the regulatory standards you have direct experience with (check all that apply): * 21 CFR 820 EU MDR ISO 13485 ISO 14971 IEC 60601 IEC 62366 Do you have hands-on experience with the following? (check all that apply): * Design Controls Verification & Validation (V&V) Usability Engineering Corrective and Preventive Actions (CAPA) Change Control Have you supported new product development and design transfer into manufacturing? Select... Do you have experience supporting medical devices with software components? * Select... 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 hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file. As set forth in Lexington Medical’s 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 measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis 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 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 Labor’s 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, Parkinson’s 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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