Quality Monitoring & Improvement Specialist I

Penumbra, Inc.; Alameda (CA); On-site; USD 45,460 - 61,992; Full time

Benefits offered by this job

Generous benefits package (medical, dental, vision)

401(k) with employer match

Paid parental leave

Vacation and sick time

Job summary

Penumbra, Inc. is seeking a Quality Monitoring & Improvement Specialist I in Alameda, California. As part of the Quality team, you will ensure the adherence of life-saving products to quality and safety standards while supporting quality management processes.

The ideal candidate has a Bachelor's degree in engineering or life sciences and 1+ years in regulated environments. Responsibilities include organizing board meetings and maintaining QMS tracking systems.

Qualifications

• 1+ years of quality systems experience in a regulated medical device or pharmaceutical environment.
• High degree of accuracy and attention to detail.
• Ability to excel in a fast-paced environment.

Responsibilities

• Organizes and facilitates board meetings for QMS process documentation.
• Maintains and updates NCR/CAPA/DA tracking systems.
• Supports management during internal and external audits.

Skills

Bilingual Spanish/English fluency

Strong oral and written communication skills

Proficiency with MS Word, Excel, and PowerPoint

Ability to create basic charts and graphs in Excel

Education

Bachelor's degree in engineering, life sciences, or related field

Job description

As a key member of the Quality team, you will have a hand in ensuring 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 be supporting 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. You will also 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, but not limited to, 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.
• Supports management during internal and external audits, with guidance/support.
• Reviews quality records associated with the QMS process to ensure accuracy with the approved format and standards.
• Provides basic guidance on the assigned QMS process(es).
• Maintains control and access of quality records for the assigned QMS process.
• Cross trains on other QMS processes and provides backup and support when needed.

What You Contribute

• A Bachelor's degree preferably in engineering, life sciences, or a related field with 1+ years 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 by this job include ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception.

Base Pay Range Per Hour: $33.00 – 45.00 / 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 that is 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, 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 law(s).

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.