Quality Assurance Engineer

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

Job Summary

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.

Education & Experience

• 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.