Engineer II, Quality Complaint Management

🔥 14 hours ago

🐊 Florida – Remote

🐊 Florida – Remote

💵 $69.3k - $86.7k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

👷🏻‍♀️ Engineer

👻 Ghost score 0%

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axogen

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2002

🏥 Healthcare

⚕️ Healthcare Insurance

🧬 Biotechnology

💰 $17.5M Post-IPO Equity on 2015-08

Healthcare • Healthcare Insurance • Biotechnology

Axogen is a company focused on revolutionizing the science of nerve repair. It provides technology and solutions aimed at restoring feeling and functionality to damaged peripheral nerves. Axogen works with healthcare professionals and patients to offer proven nerve repair solutions, such as the Avance® Nerve Graft, which have helped individuals recover from serious nerve injuries. By delivering innovative healthcare options, Axogen aims to restore hope and improve the quality of life for patients experiencing chronic pain, loss of function, or numbness due to nerve damage.

📋 Description

• Serve as the principal complaint investigator and manage complaint system performance • Support investigations of complaints for all Axogen product lines • Draft and submit Health Hazard Evaluation Assessments, Field Alert Reports, and Medical Device Reports for review and regulatory submission • Support interactions with FDA and other regulatory bodies regarding complaint responses, status, and reportability determinations • Drive and report complaint management system performance, including complaint trending, on-time closure, and regulatory reporting timeliness • Coordinate interactions among complaint reporters, Quality Engineering, Medical Affairs, and Regulatory Affairs • Coordinate Adverse Event determinations and pharmacovigilance reporting to Medical Affairs • Report complaint program status and issues to Senior Management • Revise and approve controlled documents associated with the complaint system • Train personnel on the complaint system and improve training • Support regulatory and notified body inspections as a subject matter expert • Report to the Manager, Quality Systems

🎯 Requirements

• Bachelor’s degree in a scientific or medical discipline required • At least 2 years’ experience in the pharmaceutical or medical device industry required, or five years’ experience with a Master’s degree or above • Minimum of one year of experience working with medical device and/or pharmaceutical complaints • Working experience managing a complaint system compliant with 21 CFR 211, 600, 820, 1271 and international standards 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

🏖️ Benefits

• 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 • Employee Stock Purchase Plan • Referral incentive program • Annual bonus eligibility • 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