KH
Quality Assurance Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
Mid level
1 week ago
- FMEA
- Risk Management
- PFMEA
- GD&T
- CAPA
- Lean Six Sigma
1 week ago
We are seeking an experienced Quality Assurance Engineer – Medical Devices to support quality engineering activities throughout the product development and manufacturing lifecycle. The ideal candidate will have strong experience in medical device quality, process verification and validation, Design/Process FMEA, Design Controls, risk management, and product testing.
Roles and Responsibilities
- Conduct and support Process Verification and Process Validation (PV/PPQ) activities in accordance with established procedures and regulatory requirements.
- Develop, review, and maintain Design FMEA (DFMEA) and Process FMEA (PFMEA) documentation.
- Support Design Control activities throughout the product development lifecycle.
- Perform product and process risk management and risk assessments.
- Support product testing, verification, and validation activities and ensure appropriate documentation is completed.
- Interpret engineering blueprints, drawings, GD&T, and technical specifications.
- Participate in New Product Development (NPD) activities and provide quality engineering support from development through production implementation.
- Support CAPA, nonconforming material, deviation, and corrective/preventive action processes.
- Investigate quality issues using structured root-cause analysis and problem-solving methodologies.
- Support compliance with applicable medical device quality and regulatory requirements.
- Collaborate with manufacturing and onsite teams to ensure successful implementation of validated processes and quality requirements.
- Work cross-functionally with Engineering, Manufacturing, R&D, Regulatory, Operations, and other stakeholders to resolve quality issues.
- Participate in continuous improvement initiatives using Lean, Six Sigma, and other quality improvement methodologies.
- Provide quality input and technical support to senior leadership on quality initiatives and improvement programs.
- Manage multiple projects and priorities while meeting established timelines and quality objectives.
- Prepare, review, and maintain quality documentation, reports, and technical records.
- Bachelor's degree in engineering, Science, or another relevant technical discipline.
- 5+ years of experience in the medical device industry, preferably in Quality Engineering or Quality Assurance.
- Hands-on experience with Process Verification and Validation.
- Experience with risk management, product testing, and quality problem-solving.
Quality Assurance Engineer · Katalyst Healthcares & Life Sciences