Product Surveillance Specialist I
Job Summary
Job Description
As a key member of the Quality Assurance team, you will ensure Penumbra's life-saving products meet the highest standards of quality and safety. You will provide timely and accurate support for quality processes related to post-market complaints, ensuring compliance with procedures and regulatory requirements. Responsibilities include receiving, evaluating, and responding to customer comments and complaints, coordinating product returns, assisting in categorizing potential complaints, ensuring timely reporting and communication, maintaining correspondence and data entry, coordinating audits, supporting management during inspections and audits, interfacing with other departments on quality issues, and providing guidance to staff on product surveillance. A High School diploma with 3+ years of quality systems experience in a regulated device or pharmaceutical environment is required. A Bachelor's degree in Life Science is preferred. Strong attention to detail, organizational skills, and the ability to manage multiple tasks and meet deadlines are essential.
Must have:
- High School diploma
- 3+ years of quality systems experience
- Attention to detail
- Organizational skills
- Ability to juggle tasks and meet deadlines
- Familiarity with standard office software
- Strong written and verbal communication skills
Good to have:
- Bachelor's degree in Life Science
Perks:
- Collaborative teamwork environment
- Generous benefits package
- Medical, dental, vision insurance
- Life, AD&D, short and long-term disability insurance
- 401(k) with employer match
- Employee stock purchase plan
- Paid parental leave
- Eleven paid company holidays
- Minimum of fifteen days of accrued vacation
- Paid sick time
5 skills required
Job Details
As a key member of our Quality Assurance team, you will have a hand in ensuring that Penumbra's life-saving products adhere to the highest standards of quality and safety. By providing timely and accurate support of quality processes related to post-market complaints, you will help to ensure that we are in compliance with all applicable procedures and regulatory requirements. You will receive, evaluate, and respond to customer comments and complaints related to products distributed by Penumbra.
What You’ll Work On
• Receive, evaluate, and respond to customer comments and complaints related to products distributed by Penumbra.
• Coordinate product return, receiving and processing.
• Assist in defining and categorizing potential complaints and reportable events.
• Ensure that any necessary reporting and communication occur in an appropriate and timely manner.
• Maintain accurate and timely correspondence and data entry.
• Coordinate periodic audits of records and files to ensure that appropriate procedures have been followed.
• Support management during FDA inspections, FDB inspections, and notified body audits.
• Interface with other departments and customers on quality-related issues.
• Provide guidance and training for other staff on product surveillance issues and procedures.
What You Contribute
• A High School diploma required with 3+ years of quality systems experience in a regulated device or pharmaceutical environment or an equivalent combination of education and experience.
• Bachelor’s degree in Life Science preferred.
• Requires keen attention to detail, excellent organizational skills, and the ability to juggle multiple tasks and meet deadlines.
• Familiarity with standard office software packages.
• Strong written and verbal communication skills are required.
Working Conditions
General office environment. Business travel from 0 % - 10%. Requires some lifting and moving of up to 25 pounds. Must be able to move between buildings and floors. Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. Must be able to read, prepare emails, and produce documents and spreadsheets. Must be able to move within the office and access file cabinets or supplies, as needed. Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.
Base Pay Range Per Hour: $27.00 – 33.00 / hour
Individual compensation will vary based on factors such as qualifications, skill level, competencies, work location and shift, and will increase over time based on meeting performance and business needs.
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, 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 law(s).
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 in markets 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 the State of California, please also 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.
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