Engineer II, Quality Complaint Management

Engineer II, Quality Complaint Management

Alachua, Florida, United States;
Tampa, Florida, United States;
Remote

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!

Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.

Why you'll love working at Axogen:

• Friendly, open, and fun team culture that values unique perspectives
• Company-wide dedication to profoundly impacting patients' lives
• Comprehensive, high-quality benefits package effective on date of hire
• Educational assistance available for all employees
• Matching 401(k) retirement plan
• Paid holidays, including floating holidays, to be used at your discretion
• Employee Stock Purchase Plan
• Referral incentive program

Axogen Mission and Business Purpose

Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.

Job Summary of the Engineer II, Quality Complaint Management

This position reports to the Manager, Quality Systems, and is responsible for the process management of the complaint system. This includes serving as the principle complaint investigator and managing performance of the system.

Requirements of the Engineer II, Quality Complaint Management

• Bachelor's degree in a scientific or medical discipline required
• At least 2 years' experience (five years' with a Master's degree or above) in the pharmaceutical or medical device industry required with a minimum of one year of experience working with medical device and/or pharmaceutical complaints
• Working experience managing a complaint system compliant 21 CFR 211, 600, 820, 1271 and international standards is strongly preferred
• Independent decision-making with high initiative
• Strong oral and written communication, collaboration, and interpersonal skills with those from diverse technical backgrounds
• Well-organized, with the ability to efficiently manage multiple, competing priorities
• Ability to assess and apply risk management principles per ISO 14971 and ICH Q9

Responsibilities of the Engineer II, Quality Complaint Management

The specific duties of the Engineer II, Quality Complaint Management include but are not limited to:

• Support investigator on complaints for all Axogen product lines.
• Drafts and submits Health Hazard Evaluation Assessments (HHEAs), Field Alert Reports (FARs) and Medical Device Reports (MDRs) for review by Senior Management and submission to FDA or other regulatory bodies
• Supports interactions with FDA or other regulatory bodies regarding complaint response, status, and reportability determinations
• Drives and reports on the performance of the complaint management system, including but not limited to: complaint trending, on time closure, and timeliness of regulatory reporting
• Supports interactions between complaint reporters, Quality Engineering, Medical Affairs, and Regulatory Affairs to ensure complaints are reported and assessed in a timely way
• Coordinates timely Adverse Event determination and pharmacovigilance reporting to Medical Affairs
• Reports on complaint program status and issues to Senior Management
• Revises and approves controlled documents associated with the complaint system
• Trains personnel on the complaint system and improving training
• Supporting regulatory and notified body inspections as a subject matter expert

Location

13631 Progress Blvd., Alachua, FL 32615

OR

111 West Oak Ave., Tampa, FL…