Engineer II, Quality Complaint Management

Axogen • Tampa, FL

1d • Remote

About The Position

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

• 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

• 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

Benefits

• Health
• Dental
• Vision
• Matching 401K
• 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
• Employee Stock Purchase Plan
• Disability Insurance
• Annual bonus

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level