KH
Quality Assurance Engineer
Katalyst Healthcares & Life Sciences
- 🇺🇸 United States
- On-site
- Manager or above
- 8 hours ago
- Risk Management
- Regulatory Compliance
- FMEA
- CAPA
- PFMEA
- GD&T
- Lean Six Sigma
8 hours ago
We are seeking an experienced Quality Assurance Engineer to support quality engineering activities within the medical device industry. The ideal candidate will have strong experience in design quality engineering, design controls, process verification and validation, risk management, and regulatory compliance. This role involves conducting Design and Process Failure Mode and Effects Analysis (FMEA), supporting Corrective and Preventive Actions (CAPA), managing nonconforming materials, and ensuring product quality and compliance with applicable medical device regulations. The candidate will collaborate with cross-functional teams, onsite personnel, and senior leadership to drive continuous improvement and support successful product and process implementation.
Roles and Responsibilities
- Conduct process verification and validation activities to ensure manufacturing processes meet established quality and regulatory requirements.
- Perform Design FMEA (DFMEA) and Process FMEA (PFMEA) to identify, assess, and mitigate potential product and process risks.
- Support design quality engineering activities, including design reviews, design verification, and design validation.
- Ensure compliance with design control requirements and applicable medical device quality system regulations.
- Interpret engineering blueprints, technical drawings, and Geometric Dimensioning and Tolerancing (GD&T) specifications.
- Perform risk management activities and support product testing to verify product quality, safety, and performance.
- Support CAPA investigations, root cause analysis, and implementation of effective corrective and preventive actions.
- Participate in the identification, investigation, and resolution of nonconforming materials and quality issues.
- Collaborate with cross-functional engineering, manufacturing, and quality teams to ensure successful implementation of processes and product changes.
- Support regulatory compliance activities, quality documentation, and maintenance of relevant records.
- Identify opportunities for continuous improvement using Lean, Six Sigma, and other quality improvement methodologies.
- Manage multiple projects and priorities while ensuring timely completion of quality engineering deliverables.
- Communicate quality risks, project updates, and improvement initiatives to stakeholders and senior leadership.
- Work closely with onsite teams to resolve technical challenges and ensure consistent implementation of quality requirements.
- Bachelor's degree in technical or scientific discipline, such as engineering, life sciences, or a related field.
- Bachelor's degree in mechanical engineering, Biomedical Engineering, Bioengineering, or a related engineering discipline.
- Minimum of 5 years of experience in the medical device industry.
- Hands-on experience with process verification and validation.
- Experience performing Design FMEA and/or Process FMEA.
- Experience in Design Quality Engineering and design control processes.
Quality Assurance Engineer · Katalyst Healthcares & Life Sciences