Quality Assurance Engineer III

EPM Scientific; Boston (MA); On-site; 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

Overview

A client I'm working with is seeking a motivated and detail‑oriented Quality Assurance Engineer III to join their team in supporting the development, manufacture, and ongoing reliability of our medical device products. In this role, you will help ensure that their quality processes, documentation, and product performance meet the expectations of both our internal standards and the broader regulatory environment.

Qualifications

• Knowledge and experience of ISO 13485 and process validation
• Demonstrated experience participating in audits or supporting inspection readiness activities.
• Familiarity with common problem-solving tools (e.g., 5 Whys, Ishikawa, fault tree thinking, Pareto analysis).
• Experience working with electronic quality systems (eQMS), document control tools, PLM systems, or similar platforms.

Responsibilities

• Partner with cross‑functional teams to provide quality guidance during development, manufacturing, and continuous improvement efforts.
• Contribute to investigations, root‑cause analysis, and implementation of corrective and preventive actions.
• Participate in risk‑based decision‑making, supporting assessment, mitigation, and ongoing evaluation of product and process risks.
• Support internal and external audits by preparing evidence, addressing observations, and promoting inspection readiness.
• Competitive compensation package
• Bonus and LTI's

Benefits

• Competitive compensation package
• Bonus and LTI's

We invite motivated candidates who are passionate about quality and patient safety to apply and join a team dedicated to supporting reliable, compliant, and impactful medical device solutions.