Quality Engineer
About The Position
Under broad supervision, the Quality Engineer independently manages post-market quality activities to ensure compliance with applicable regulatory requirements and quality system standards. The role conducts complaint investigations, evaluates post-market surveillance data, performs trend analysis, supports Medical Device Reporting (MDR) and Vigilance activities, and leads corrective and preventive action (CAPA) initiatives. The Quality Engineer collaborates cross-functionally to identify quality risks, assess product performance in the field, and drive continuous improvement to maintain product safety and effectiveness. The position also supports quality system reviews, audits and inspections, field actions, recalls, health hazard evaluations, regulatory inquiries, and management review activities. It works with Regulatory Affairs, Medical Affairs, Operations, and Product Management on product safety concerns and compliance with FDA, ISO 13485, MDR, and other applicable requirements.
Requirements
- Bachelor’s degree in engineering, science, math, or another related technical field; the posting states this is typically required.
- At least 2 years of experience in Quality or Engineering.
- Ability to develop ways of accomplishing goals with little or no supervision, complete objectives independently, and determine when issue escalation is necessary.
- Time management skills to prioritize, organize, and track details while meeting deadlines across multiple projects.
- Problem-solving experience, including overcoming obstacles and reaching successful solutions through mathematical or systematic operations.
- Experience using Microsoft Office Suite products, including Word, Excel, PowerPoint, and Outlook.
- Intermediate Microsoft Excel skills, such as conditional formatting, tables, formulas, and charting.
Nice To Haves
- At least 2 years of experience in complaint handling, post-market surveillance, MDR/Vigilance reporting, CAPA management, risk management, field actions, or medical device quality systems.
- Experience working with FDA 21 CFR Part 803, Part 820/QMSR, ISO 13485, EU MDR post-market requirements, and complaint handling processes.
- Experience performing complaint investigations, trend analysis, and regulatory reporting within the medical device industry.
Responsibilities
- Manage and execute post-market surveillance, including complaint trending, adverse event monitoring, and analysis of product performance data to identify emerging quality and safety concerns.
- Conduct complaint investigations; determine reportability and root cause; and identify appropriate corrective actions.
- Support regulatory reporting requirements, including Medical Device Reports (MDRs), Vigilance Reports, and other global post-market submissions.
- Analyze complaint, audit, service, and field performance data to identify trends, assess risk, and recommend quality improvements; apply statistical techniques to support data-driven decisions.
- Lead and support investigations of nonconformances, complaints, adverse events, and field issues.
- Develop, implement, and verify CAPAs to address identified risks and systemic issues.
- Partner with Regulatory Affairs, Medical Affairs, Operations, and Product Management to assess product safety concerns and support field actions, recalls, health hazard evaluations, and regulatory inquiries as required.
- Review and evaluate complaint records, investigation documentation, CAPAs, and quality records for compliance with applicable requirements.
- Prepare quality metrics, trend reports, and post-market surveillance summaries for management reviews, and monitor quality system process effectiveness.
- Participate in internal and external audits and support inspections related to complaint handling, post-market surveillance, MDR reporting, and CAPA processes.
Benefits
- Competitive total rewards package
- Continuing education and training
- Health insurance
- Life insurance
- Disability insurance
- 401(k) contributions
- Paid time off
- Bonus and/or incentive eligibility
- Employee Assistance Program access for employees working less than 30 hours per week
- Employee Resource Groups
- Employee Service Corp
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
