Penumbra, Inc.
Quality Monitoring & Improvement Specialist I
Penumbra, Inc., Alameda, California, United States, 94501
Quality Monitoring & Improvement Specialist I
Join to apply for the
Quality Monitoring & Improvement Specialist I
role at
Penumbra, Inc. As a key member of the Quality team, you will help ensure that Penumbra's life-saving products adhere to the highest standards of quality and safety. In the Quality Monitoring & Improvement Specialist I role, you will support our Quality Management System (QMS) processes, specifically Corrective and Preventive Actions (CAPAs), Nonconformance Reports (NCRs) and Deviation Authorizations (DAs) following Penumbra\'s procedures and regulatory requirements. You will organize and host board meetings to facilitate board review of documentation supporting these systems and assist with data compilation for monthly trending meetings.
What You’ll Work On
Organizes and facilitates board meetings with guidance to review assigned QMS process documentation, giving regular status updates
Communicates with NCR/CAPA/DA owners to obtain status updates or provide reminders about upcoming due dates
Maintains and updates NCR/CAPA/DA tracking systems
Prioritizes routing QMS process documentation for approvals. Follows up with approvers if response is not received in a reasonable timeframe
Collaborates and communicates cross-functionally with teams including Manufacturing Engineering, Quality Engineering, Regulatory Affairs, R&D and Production
Assists with data compilation for monthly trending meetings
Receives data requests (charts, graphs, etc.) and implements the changes with guidance/support
What You Contribute
A Bachelor\'s degree preferably in engineering, life sciences, or a related field with 1+ year of quality systems experience in a regulated medical device or pharmaceutical environment, or an equivalent combination of education and experience
Bilingual Spanish/English fluency is a plus
Medical device, pharmaceutical, biotech, or other regulated industry experience desired
Strong oral, written and interpersonal communication skills
High degree of accuracy and attention to detail
Proficiency with MS Word, Excel, and PowerPoint
Ability to create basic charts and graphs for data analysis in Excel
Excellent organizational, interpersonal, and verbal and written communication skills, with high attention to detail and the ability to deliver quality outputs under supervision
Ability to excel in a fast-paced environment
Working Conditions
General office environments. The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. Specific vision abilities required include reading, close, distance, color, peripheral, and depth perception.
Base Pay Range Per Hour : $32.00 – 43.00 / hour
Individual compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
What We Offer
A collaborative teamwork environment where learning is constant, and performance is rewarded
The opportunity to be part of the team revolutionizing the treatment of some of the world\'s most devastating diseases
A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year (which increases with tenure), and paid sick time in compliance with applicable laws
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
If you reside in California, please refer to Penumbra\'s Privacy Notice for California Residents. For additional information on Penumbra\'s commitment to being an equal opportunity employer, please see Penumbra\'s AAP Policy Statement.
Seniority level
Entry level Employment type
Full-time Job function
Quality Assurance Industries
Medical Equipment Manufacturing Referrals increase your chances of interviewing at Penumbra, Inc. by 2x
#J-18808-Ljbffr
Join to apply for the
Quality Monitoring & Improvement Specialist I
role at
Penumbra, Inc. As a key member of the Quality team, you will help ensure that Penumbra's life-saving products adhere to the highest standards of quality and safety. In the Quality Monitoring & Improvement Specialist I role, you will support our Quality Management System (QMS) processes, specifically Corrective and Preventive Actions (CAPAs), Nonconformance Reports (NCRs) and Deviation Authorizations (DAs) following Penumbra\'s procedures and regulatory requirements. You will organize and host board meetings to facilitate board review of documentation supporting these systems and assist with data compilation for monthly trending meetings.
What You’ll Work On
Organizes and facilitates board meetings with guidance to review assigned QMS process documentation, giving regular status updates
Communicates with NCR/CAPA/DA owners to obtain status updates or provide reminders about upcoming due dates
Maintains and updates NCR/CAPA/DA tracking systems
Prioritizes routing QMS process documentation for approvals. Follows up with approvers if response is not received in a reasonable timeframe
Collaborates and communicates cross-functionally with teams including Manufacturing Engineering, Quality Engineering, Regulatory Affairs, R&D and Production
Assists with data compilation for monthly trending meetings
Receives data requests (charts, graphs, etc.) and implements the changes with guidance/support
What You Contribute
A Bachelor\'s degree preferably in engineering, life sciences, or a related field with 1+ year of quality systems experience in a regulated medical device or pharmaceutical environment, or an equivalent combination of education and experience
Bilingual Spanish/English fluency is a plus
Medical device, pharmaceutical, biotech, or other regulated industry experience desired
Strong oral, written and interpersonal communication skills
High degree of accuracy and attention to detail
Proficiency with MS Word, Excel, and PowerPoint
Ability to create basic charts and graphs for data analysis in Excel
Excellent organizational, interpersonal, and verbal and written communication skills, with high attention to detail and the ability to deliver quality outputs under supervision
Ability to excel in a fast-paced environment
Working Conditions
General office environments. The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. Specific vision abilities required include reading, close, distance, color, peripheral, and depth perception.
Base Pay Range Per Hour : $32.00 – 43.00 / hour
Individual compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
What We Offer
A collaborative teamwork environment where learning is constant, and performance is rewarded
The opportunity to be part of the team revolutionizing the treatment of some of the world\'s most devastating diseases
A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year (which increases with tenure), and paid sick time in compliance with applicable laws
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
If you reside in California, please refer to Penumbra\'s Privacy Notice for California Residents. For additional information on Penumbra\'s commitment to being an equal opportunity employer, please see Penumbra\'s AAP Policy Statement.
Seniority level
Entry level Employment type
Full-time Job function
Quality Assurance Industries
Medical Equipment Manufacturing Referrals increase your chances of interviewing at Penumbra, Inc. by 2x
#J-18808-Ljbffr