Note: The job is a remote job and is open to candidates in USA. Axogen is dedicated to restoring peripheral nerve function and improving patients’ quality of life. The Sr. Engineer, Quality Complaint Management is responsible for managing the complaint system, serving as the principal complaint investigator, overseeing system performance, and supporting regulatory reporting and inspections.
Responsibilities
- Being the lead investigator on tissue and biologics complaints
- Supporting Quality Engineering in the investigation of medical device complaints
- Drafting and submitting 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
- Lead interactions with FDA or other regulatory bodies regarding MDR and FARs report status and closure
- Monitoring and reporting on the performance of the complaint management system, including but not limited to: complaint trending, on time closure, and timeliness of regulatory reporting
- Coordinating interactions between complaint reporters, Quality Engineering, Medical Affairs, and Regulatory Affairs to ensure complaints are reported and assessed in a timely way
- Coordinating timely Adverse Event determination and reporting to Medical Affairs
- Report on complaint program status and issues to Senior Management
- Revising and approving controlled documents associated with the complaint system
- Training personnel on the complaint system
- Supporting regulatory and notified body inspections
Skills
- Bachelor's degree in a scientific or medical discipline required
- At least five years' experience (three 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
- 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
- Working experience managing a complaint system compliant 21 CFR 211, 600, 820, 1271 and international standards is preferred
Benefits
- 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
- Annual bonus
- Health insurance
- Dental insurance
- Vision insurance
- 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
Company Overview
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