EPS Connects LLC
Quality Assurance Engineer Medical Device Manufacturing (Onsite | Watertown, CT)
Are you ready to take on a hands-on quality leadership role in a highly regulated, fast-paced manufacturing environment? Were looking for a
Quality Assurance Engineer
to join a global medical device manufacturer known for technical excellence, precision manufacturing, and continuous innovation. This role offers the opportunity to play a
key part in ensuring compliance, quality, and safety
across multiple programs supporting advanced medical and life science technologies. If you thrive in an environment where engineering rigor meets real-world impact this could be the next step in your career. What Youll Do Drive compliance and quality excellence:
Ensure all processes meet FDA (21 CFR Part 820), ISO 13485, and global regulatory standards. Be audit-ready at all times:
Support internal and external audits, ensuring full compliance and documentation integrity. Lead risk and failure analysis:
Conduct risk assessments, FMEA, and implement effective CAPA strategies to improve process robustness and patient safety. Partner across disciplines:
Collaborate closely with R&D, Manufacturing, and Regulatory Affairs to ensure quality is built into every stage of product development and production. Champion documentation and testing rigor:
Develop, execute, and validate test protocols, maintaining thorough records and applying sound statistical analysis. Train and influence:
Share best practices, conduct quality and compliance training, and build a culture of continuous improvement. What You Bring Bachelors degree in
Engineering, Life Sciences, or related field . 3+ years
of experience in a regulated manufacturing environment (medical device preferred). Deep understanding of
FDA, ISO 13485, and 21 CFR Part 820
standards. Hands-on experience with
root cause analysis, CAPA, FMEA, validation, and data-driven problem-solving . Proficiency with tools such as
Minitab, Excel, Power BI, SolidWorks, or ERP/QMS platforms . Professional certifications such as
CQE, Six Sigma, or ISO 13485 Lead Auditor
are highly valued. Why Youll Love It A culture that values
technical excellence, precision, and problem-solving . The opportunity to
work with cutting-edge medical technologies
that directly improve lives. A mix of
hands-on work and strategic quality leadership
ideal for someone who wants both responsibility and visibility. Competitive compensation, strong mentorship, and the chance to grow within a leading medical manufacturing organization.
Quality Assurance Engineer
to join a global medical device manufacturer known for technical excellence, precision manufacturing, and continuous innovation. This role offers the opportunity to play a
key part in ensuring compliance, quality, and safety
across multiple programs supporting advanced medical and life science technologies. If you thrive in an environment where engineering rigor meets real-world impact this could be the next step in your career. What Youll Do Drive compliance and quality excellence:
Ensure all processes meet FDA (21 CFR Part 820), ISO 13485, and global regulatory standards. Be audit-ready at all times:
Support internal and external audits, ensuring full compliance and documentation integrity. Lead risk and failure analysis:
Conduct risk assessments, FMEA, and implement effective CAPA strategies to improve process robustness and patient safety. Partner across disciplines:
Collaborate closely with R&D, Manufacturing, and Regulatory Affairs to ensure quality is built into every stage of product development and production. Champion documentation and testing rigor:
Develop, execute, and validate test protocols, maintaining thorough records and applying sound statistical analysis. Train and influence:
Share best practices, conduct quality and compliance training, and build a culture of continuous improvement. What You Bring Bachelors degree in
Engineering, Life Sciences, or related field . 3+ years
of experience in a regulated manufacturing environment (medical device preferred). Deep understanding of
FDA, ISO 13485, and 21 CFR Part 820
standards. Hands-on experience with
root cause analysis, CAPA, FMEA, validation, and data-driven problem-solving . Proficiency with tools such as
Minitab, Excel, Power BI, SolidWorks, or ERP/QMS platforms . Professional certifications such as
CQE, Six Sigma, or ISO 13485 Lead Auditor
are highly valued. Why Youll Love It A culture that values
technical excellence, precision, and problem-solving . The opportunity to
work with cutting-edge medical technologies
that directly improve lives. A mix of
hands-on work and strategic quality leadership
ideal for someone who wants both responsibility and visibility. Competitive compensation, strong mentorship, and the chance to grow within a leading medical manufacturing organization.