Product Surveillance Specialist I

About the position

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.

Responsibilities

• 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.

Requirements

• 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.

Benefits

• Medical, dental, vision, 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 per year.
• A minimum of fifteen days of accrued vacation per year, which increases with tenure.
• Paid sick time in compliance with applicable law(s).