Quality Monitoring & Improvement Specialist Role at Penumbra, Inc. USA
Penumbra is hiring a Quality Monitoring & Improvement Specialist I in Alameda, CA. This life science job allows you to ensure that Penumbra’s life-saving medical devices meet the highest standards of quality and safety while supporting QMS processes like CAPAs, NCRs, and Deviation Authorizations.
Job Details:
- Job Title: Quality Monitoring & Improvement Specialist
- Location: Alameda, CA
- Base Pay Range: $32.00 – $43.00/hour
- Job Type: Full-time
- Work Environment: Office-based with occasional standing, walking, and extended computer use. Vision requirements include close, distance, color, peripheral vision, and depth perception.
About Penumbra:
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company delivering innovative therapies. Penumbra develops, manufactures, and markets novel products to treat challenging medical conditions in markets with unmet needs. Products are sold through direct sales in the U.S., Europe, Canada, Australia, and select international markets.
Educational Requirements:
- Bachelor’s degree in Life Sciences, or a related field.
- 1+ years of experience in regulated medical device, pharmaceutical, or biotech quality systems, or equivalent combination of education and experience.
- Bilingual Spanish/English fluency is a plus.
Key Responsibilities for Quality Monitoring & Improvement Specialist:
- Organize and facilitate board meetings to review QMS documentation.
- Track and maintain CAPA, NCR, and DA systems.
- Communicate with process owners regarding updates and deadlines.
- Compile data for monthly trending meetings and create charts/graphs.
- Support management during internal and external audits.
- Review quality records for accuracy and compliance.
- Cross-train on QMS processes and provide backup support.
Skills Required:
- Strong oral, written, and interpersonal communication.
- High accuracy and attention to detail.
- Proficiency in MS Word, Excel, and PowerPoint.
- Ability to create charts and graphs for data analysis.
- Excellent organizational skills and ability to perform in fast-paced environments.
Benefits of the Quality Monitoring & Improvement Specialist Role:
- Collaborative and learning-focused team environment.
- Competitive pay with performance-based rewards.
- Medical, dental, vision, life, and disability insurance.
- 401(k) with employer match and employee stock purchase plan.
- Paid parental leave, company holidays, vacation, and sick leave.
- These Life Science Job opportunities involve working on life-changing medical therapies.
