Senior Medical Device QA Engineer - Design & Compliance

Katalyst-Healthcares-; Boston (MA); On-site; USD 90,000 - 150,000; Full time

Job summary

Katalyst-Healthcares- seeks an experienced Quality Assurance Engineer to support quality engineering activities in the medical device sector. You will lead DFMEA/PFMEA, CAPA, and risk management efforts while ensuring compliance with design controls and regulatory requirements.

Collaborate with cross-functional teams, onsite personnel, and leadership to drive continuous improvement, manage nonconforming materials, and support product and process implementation across manufacturing and quality

Qualifications

• Bachelor's degree in engineering, life sciences, or related field.
• Minimum 5 years of experience in the medical device industry.
• Hands-on experience with process verification and validation.
• Experience performing DFMEA and/or PFMEA.
• Experience in design quality engineering and design controls.

Responsibilities

• Conduct DFMEA and PFMEA to identify and mitigate risks.
• Perform process verification and validation of manufacturing processes.
• Support design quality engineering activities, including design reviews and validation.
• Ensure compliance with design control requirements and medical device quality system regs.
• Interpret GD&T and engineering drawings.
• Perform risk management activities and support product testing to verify quality, safety, and performance.
• Support CAPA investigations and root cause analysis.
• Investigate nonconforming materials and quality issues.
• Collaborate with cross-functional teams to implement process and product changes.
• Support regulatory compliance activities and maintenance of quality records.
• Identify opportunities for Lean, Six Sigma improvements.
• Manage multiple projects and priorities with timely deliverables.
• Communicate quality risks and updates to leadership.
• Work with onsite teams to resolve technical challenges.

Skills

Design quality engineering

DFMEA / PFMEA

CAPA

Risk management

Regulatory compliance

Process verification & validation

Lean Six Sigma

Cross-functional teamwork

Education

Bachelor's degree in engineering or life sciences

Job description

Katalyst-Healthcares- seeks an experienced Quality Assurance Engineer to support quality engineering activities in the medical device sector. You will lead DFMEA/PFMEA, CAPA, and risk management efforts while ensuring compliance with design controls and regulatory requirements.

Collaborate with cross-functional teams, onsite personnel, and leadership to drive continuous improvement, manage nonconforming materials, and support product and process implementation across manufacturing and quality