QA Engineer III — Drive Compliance, Risk & Patient Safety

EPM Scientific; Boston (MA); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Competitive compensation package

Bonus and long-term incentives

Job summary

A medical device company is looking for a motivated Quality Assurance Engineer III to enhance their quality processes and regulatory compliance. The role involves ensuring product reliability and supporting audits, investigations, and quality guidance. Ideal candidates should have experience with ISO 13485, problem-solving tools, and electronic quality systems. This position offers a competitive compensation package and the opportunity to impact patient safety positively.

Qualifications

• Knowledge and experience of ISO 13485 and process validation.
• Demonstrated experience participating in audits or supporting inspection readiness activities.
• Familiarity with problem-solving tools like 5 Whys and Pareto analysis.
• Experience working with electronic quality systems (eQMS), document control tools.

Responsibilities

• Partner with teams for quality guidance during development and manufacturing.
• Contribute to investigations and corrective actions.
• Participate in risk-based decision-making for product risks.
• Support audits by preparing evidence and promoting inspection readiness.

Skills

ISO 13485 knowledge

Experience in audits

Problem-solving tools familiarity

Experience with eQMS

Job description

A medical device company is looking for a motivated Quality Assurance Engineer III to enhance their quality processes and regulatory compliance. The role involves ensuring product reliability and supporting audits, investigations, and quality guidance. Ideal candidates should have experience with ISO 13485, problem-solving tools, and electronic quality systems. This position offers a competitive compensation package and the opportunity to impact patient safety positively.