Overview In this role you will provide process and quality engineering support for the manufacture and development of combination medical devices, ensuring high-quality products for customers. You will lead root-cause analyses, CAPAs, and quality plans to drive continuous improvement in a regulated setting. You will implement monitoring systems and risk analyses to minimize defects and variability, while ensuring compliance with relevant regulations. This onsite role offers collaboration with cross-functional teams in a mission-driven environment focused on patient outcomes.
Responsibilities- Lead efforts to reduce manufacturing defects (scrap, nonconforming material, customer complaints) through root-cause analysis and corrective/preventive actions
- Potentially implement product stops and document release criteria
- Develop and implement product quality plans, quality specifications, quality plans, risk analyses and FMEAs with product development teams
- Develop and implement Process Monitoring Systems to identify critical steps and reduce defects
- Collect and analyze defect data and lead product/process improvement initiatives
- Create quality tools and training materials and communicate with relevant teams
- Evaluate adequacy and compliance of systems and practices against regulations and company documentation; may audit areas of the quality system
- Serve as technical lead in audits for 21 CFR Part 4 compliance and maintain ongoing compliance and continuous improvement for the manufacture of combination medical devices
- Perform analysis to identify trends and opportunities for corrective actions related to 21 CFR Part 4 products
- Approve final Process Monitor Release for products prior to distribution
Key requirements- Bachelor in Chemical Engineering, Chemistry or related field
- Minimum 5 years of relevant manufacturing experience
- Regulated industry experience
- Knowledge of statistical methods (trend analysis, Pareto, etc.)
- Strong verbal and written communication
- Decision making and negotiation skills
- Ability to manage multiple projects across disciplines
- Statistical methods (trend analysis, Pareto)
- 21 CFR Part 4 compliance
- cGMP knowledge for drug-device combinations
