Sr. Engineer, Quality Compliant Management

About the Role

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 principal complaint investigator and managing performance of the system.

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

Requirements

• 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

Location

13631 Progress Blvd., Alachua, FL 32615 OR 111 West Oak Ave., Tampa, FL 33602 OR Remote

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

Pay

This position is eligible for an annual bonus. Salary range: $84,190—$105,237 USD.