EPS Connects LLC
Overview
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? We’re 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 You’ll 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
Bachelor’s 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 You’ll 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.
Seniority level
Associate
Employment type
Full-time
Job function
Quality Assurance and Engineering
Industries
Medical Equipment Manufacturing
Get notified when a new job is posted.
#J-18808-Ljbffr
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? We’re 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 You’ll 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
Bachelor’s 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 You’ll 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.
Seniority level
Associate
Employment type
Full-time
Job function
Quality Assurance and Engineering
Industries
Medical Equipment Manufacturing
Get notified when a new job is posted.
#J-18808-Ljbffr