Sr. Engineer, Complaint Management
Axogen is committed to building and maintaining a strong and gratifying company culture that fosters a work-life balance and 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 the leading company revolutionizing the science of nerve repair. We are passionate about helping to restore function and quality of life to patients with physical damage or discontinuity to peripheral nerves.
Contribute to positively impacting lives while working for a company that respects, recognizes, and values all team members!
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.
If you want to see how you can impact lives at Axogen, take a look at these inspiring patient stories: https://www.axogeninc.com/patient-stories/
Axogen is hiring for a Sr. Engineer, Complaint Management!
Job Summary of the Sr. Engineer, Complaint Management
This position reports to the Sr. Manager, Quality Systems Compliance, 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.
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
- Flexible working hours
- Paid holidays, including floating holidays, to be used at your discretion
- Employee Stock Purchase Plan
- Referral incentive program
Requirements of the Sr. Engineer, Complaint Management:
- 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
- Working experience managing a complaint system compliant 21 CFR 211, 600, 820, 1271 and international standards is 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 Sr. Engineer, Complaint Management:
- 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
Axogen is on a hybrid work schedule at some facilities, with 3 days in office and 2 days remote.
Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.
If you know someone who would be a great candidate for this position, or any others, just copy and send this link! https://grnh.se/cc84962d2us