Quality Engineer

Quality Engineer

The Quality Engineer will be based Manchester, CT, reporting to Quality Manager. In this role, you will be maintaining quality engineering programs, standards and improvements within the organization.

What a typical day looks like:

• Develop, implement, and maintain quality standards, inspection methods, validation strategies, and testing procedures to ensure compliance with ISO 13485, FDA Quality System Regulations, GMP requirements, and customer expectations.
• Lead quality engineering activities throughout the product lifecycle, including process and equipment validations (IQ/OQ/PQ), change assessments, product and process qualifications, and validation documentation to ensure a maintained state of control.
• Drive risk-based decision making by applying ISO 14971 principles through PFMEAs, hazard analyses, risk assessments, and risk mitigation activities to support product quality, patient safety, and regulatory compliance.
• Investigate nonconformances, customer complaints, returned product, and process deviations using structured problem-solving methodologies. Lead CAPA activities, root cause investigations, and continuous improvement initiatives to enhance quality performance and reduce the Cost of Poor Quality (COPQ).
• Analyze quality data, monitor process performance, and assess equipment and measurement system capability to ensure the accuracy, reliability, and integrity of quality-related information. Consolidate and communicate quality metrics and trends to management and customers as required.
• Partner closely with Manufacturing, Engineering, Compliance, Operations, and Program Management teams to resolve quality issues, support customer needs, and ensure successful implementation of quality and compliance objectives.
• Support internal, customer, supplier, and regulatory audits, provide training on quality system requirements and quality control activities, and serve as a quality representative during interactions with customers and regulatory agencies.
• Approve product, process, equipment, and validation qualifications while ensuring compliance with established quality standards, regulatory requirements, and industry best practices.

The experience we're looking to add to our team:

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Quality Engineering, or a related technical discipline. Equivalent combination of education and relevant industry experience may be considered.
• Minimum of 3 years of Quality Engineering experience in a manufacturing environment, preferably within highly regulated industries.
• Minimum of 1 year of experience in the medical device industry. ISO
  13485, ISO 14971, FDA
• Hands-on experience with CAPA systems, nonconformance investigations, root cause analysis, deviation management, and continuous improvement initiatives within a regulated manufacturing environment.

What you'll receive for the great work you provide:

• Full range of medical, dental, and vision plans
• Life Insurance
• Short-term and Long-term Disability
• Matching 401(k) Contributions
• Vacation and Paid Sick Time
• Tuition Reimbursement

Job Category:
Quality

Is Sponsorship Available? No

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process.

Please email  and we'll discuss your specific situation and next steps (

NOTE:

this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).