Role OverviewThe Quality Engineer II is a hands-on quality professional who supports manufacturing and post-manufacturing activities to ensure safe, effective, and compliant medical devices. This role is ideal for an engineer who enjoys solving technical problems, leading investigations, improving processes, and working cross-functionally to make measurable quality improvements. The QE II will play a visible role in driving product and process quality through failure analysis, validation support, risk-based decision-making, and data-driven continuous improvement in a fast-paced regulated environment.
Core Competencies1. Quality & Regulatory Expertise- Apply working knowledge of ISO 13485, FDA QMSR, GMP/GDP, and Design Controls to support compliance across product and process activities.
- Manage complaint investigations, CAPAs, nonconformances, and supplier corrective actions using structured root cause and risk-based methodologies.
- Contribute to risk management activities in accordance with ISO 14971 to help identify, assess, and mitigate product and process risks.
2. Analytical & Problem-Solving Skills- Analyze manufacturing, quality, and post-production data to identify trends, performance gaps, and improvement opportunities.
- Apply statistical and analytical tools such as SPC, control charts, Pareto analysis, sampling plans, and process capability analysis to monitor and improve process performance.
- Lead or support root cause investigations and failure analysis for nonconformances, complaints, and product performance issues, and help implement effective corrective actions.
- Develop and maintain reports, dashboards, and quality metrics that improve visibility into performance and support better decision-making.
- Translate data into clear, actionable insights for Quality leadership and cross-functional stakeholders.
3. Process & Product Excellence- Review engineering, process, and supplier changes for quality impact and support validation and implementation activities.
- Support process validation activities, including protocol development, execution, data analysis, and reporting, and perform measurement system analysis for inspection and test methods.
- Partner with Engineering and Manufacturing to improve process capability, reduce variation, and strengthen process controls.
4. Supplier & Cross-Functional Collaboration- Support supplier quality activities through investigations, corrective actions, performance monitoring, and collaboration with internal and external partners.
- Partner with Quality, Manufacturing, and Engineering to maintain process controls, inspection methods, measurement systems, and validation requirements.
- Communicate technical findings clearly and work effectively across functions to resolve issues and advance improvement initiatives.
5. Technical Communication & Documentation- Prepare clear, concise technical documentation, including protocols, reports, procedures, and quality metrics.
- Ensure traceability of complaints, CAPAs, nonconformances, supplier events, and risk management records.
6. Project & Time Management- Manage multiple assignments and projects effectively while balancing timelines, quality priorities, and regulatory requirements.
- Demonstrate ownership, sound judgment, and follow-through in completing quality engineering activities with appropriate guidance.
Qualifications & Experience- 3-5 years of Quality Engineering experience in the medical device industry, with demonstrated support for manufacturing quality and post-market activities.
- Experience with complaint handling, CAPA, nonconformance investigations, supplier quality, and risk-based problem-solving.
- Strong understanding of manufacturing support, failure analysis, process validation, inspection methods, measurement system analysis, and process capability.
- Proficiency in quality and statistical tools (Excel required; Minitab preferred); experience with dashboards or data visualization tools is a plus.
- Ability to write clear technical documentation, including protocols, reports, and procedures.
- Working knowledge of Design Controls, risk management, and regulated manufacturing environments.
- Strong organizational, communication, and collaboration skills with the ability to work effectively across functions.
EducationBachelor of Science in Biomedical Engineering, Mechanical Engineering, or a related discipline.
Additional Requirements- Occasional travel (5-10%).
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