Engineer II, Quality Complaint Management

This is a fully remote position, open to applicants in Florida.

📋 Description

• Act as the primary investigator for complaints and oversee the performance of the complaint management system.

• Assist in investigating complaints related to all Axogen product lines.

• Prepare and submit Health Hazard Evaluation Assessments, Field Alert Reports, and Medical Device Reports for review and regulatory submission.

• Facilitate communications with the FDA and other regulatory agencies concerning complaint responses, statuses, and reportability assessments.

• Monitor and report on the performance of the complaint management system, focusing on complaint trends, timely closures, and regulatory reporting accuracy.

• Coordinate communication among complaint reporters, Quality Engineering, Medical Affairs, and Regulatory Affairs.

• Manage Adverse Event determinations and pharmacovigilance reporting to Medical Affairs.

• Provide updates on the complaint program's status and challenges to Senior Management.

• Review and approve controlled documents related to the complaint management system.

• Train staff on the complaint system and enhance training programs.

• Support regulatory and notified body inspections as a subject matter expert.

• Report to the Manager of Quality Systems.

⛳️ Requirements

• A Bachelor’s degree in a scientific or medical field is required.

• A minimum of 2 years of experience in the pharmaceutical or medical device sector is required, or five years of experience with a Master’s degree or higher.

• At least one year of experience handling medical device and/or pharmaceutical complaints.

• Strong preference for candidates with experience managing a complaint system in compliance with 21 CFR 211, 600, 820, 1271 and international standards.

• Ability to make independent decisions and demonstrate high initiative.

• Excellent oral and written communication, collaboration, and interpersonal skills, particularly with individuals from diverse technical backgrounds.

• Highly organized, with the capacity to effectively manage multiple, competing priorities.

• Capability to assess and apply risk management principles according to ISO 14971 and ICH Q9.

🏝️ Benefits

• Comprehensive, high-quality benefits package effective on the date of hire.

• Educational assistance available for all employees.

• Matching 401(k) retirement plan.

• Paid holidays, including floating holidays.

• Employee Stock Purchase Plan.

• Referral incentive program.

• Eligibility for annual bonuses.

• 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.