Quality Engineer

About the role

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

Responsibilities

• 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.

Requirements

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Quality Engineering, or a related technical discipline.
• 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.
• ISO13485, 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.

Qualifications

• Equivalent combination of education and relevant industry experience may be considered.

Skills

• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Proficiency in Microsoft Office Suite.

Benefits

• Flexible work schedule.
• Comprehensive health and wellness benefits.
• Professional development opportunities.
• Employee recognition program.
• Generous paid time off.

Pay

Competitive compensation package.

Schedule

Full-time position.

Benefits

• Health insurance
• Retirement savings plan
• Flexible spending accounts
• Life and disability insurance
• Employee assistance program
• Flexible work schedule

Flex is an Equal Opportunity Employer

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 accessibility@flex.com and we'll discuss your specific situation and next steps.