Engineer II, Quality Complaint Management

About the role

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

Requirements

• 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 working with medical device and/or pharmaceutical complaints
• Experience managing a complaint system compliant with 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

• Support investigator on complaints for all Axogen product lines
• Draft and submit 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
• Support interactions with FDA or other regulatory bodies regarding complaint response, status, and reportability determinations
• Drive and report on the performance of the complaint management system, including complaint trending, on-time closure, and timeliness of regulatory reporting
• Support interactions between complaint reporters, Quality Engineering, Medical Affairs, and Regulatory Affairs to ensure complaints are reported and assessed in a timely way
• Coordinate timely Adverse Event determination and pharmacovigilance reporting to Medical Affairs
• Report on complaint program status and issues to Senior Management
• Revise and approve controlled documents associated with the complaint system
• Train personnel on the complaint system and improving training
• Support regulatory and notified body inspections as a subject matter expert

Benefits

• 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
• Health, Dental, Vision
• Paid Time Off
• 9 Paid Holidays + 3 Floating Holidays
• Dependent Care Flexible Spending Accounts
• Medical Flexible Spending Accounts
• Tuition Reimbursement
• Paid Parental Leave
• Paid Caregiver Leave
• Basic Life Insurance
• Supplemental Life Insurance
• Disability Insurance

Pay

Salary Range: $69,333—$86,666 USD

Schedule

Position may be located at 13631 Progress Blvd., Alachua, FL 32615; 111 West Oak Ave., Tampa, FL 33602; or Remote.