Quality Engineering Technician
2 days ago
New Hartford
Job Description Job Title: Quality Engineering Technician Job Description The Quality Engineering Technician provides advanced customer-facing and factory-facing quality support for contract manufacturing of medical device components. This role serves as a key technical resource for transitioning, validating, and sustaining manufacturing processes, with strong ownership of quality systems, data-driven decision-making, and cross-functional collaboration. The Quality Engineering Technician works with a high degree of independence, leads routine quality activities, mentors junior technicians and operations personnel, and drives improvements in alignment with ISO standards and 21 CFR 820 requirements. Responsibilities • Own and drive the timely processing of nonconformances, process deviations, and other quality records, ensuring thorough documentation and effective resolution., • Maintain the calibration program to ensure measurement and test equipment remains accurate, reliable, and compliant with applicable standards., • Maintain and update control plans and process FMEAs (pFMEAs) to support robust process control and risk management., • React to leading quality indicators and facilitate the execution of preventive actions to avoid potential issues before they occur., • Support document control activities, including creation, revision, and management of controlled quality documents., • Support completion of validation activities and test method validations, ensuring methods are appropriate, reliable, and properly documented., • Support corrective and preventive action (CAPA) activities by contributing to root cause analysis, action planning, and effectiveness verification., • Support continuous improvement projects focused on enhancing product quality, process capability, and operational efficiency., • Support process validation activities, including protocol execution, data collection, and data analysis to confirm process performance and compliance., • Perform and/or oversee sample preparation and testing, including tensile testing, BFR testing, DSC testing, and chemical testing, while ensuring data integrity and accuracy., • Lead inspection activities and make quality decisions for mill products such as bar, coil, and thick sheet, including providing disposition recommendations., • Author and revise quality procedures to reflect current practices, regulatory requirements, and continuous improvement initiatives., • Conduct training sessions, including onboarding and upskilling of new employees and operations personnel on quality-related processes and procedures., • Mentor junior quality technicians and operations staff, providing technical guidance and promoting best practices in quality engineering., • 5+ years of experience in a Quality Engineering Technician role for a medical device manufacturer or equivalent experience in a highly regulated environment., • Strong in quality engineering and quality assurance within manufacturing., • Proven ability to work independently and lead routine quality activities with minimal supervision., • Demonstrated experience processing nonconformances, process deviations, and other quality records., • Hands-on experience with calibration program maintenance and control of measurement and test equipment., • Experience maintaining and updating control plans and process FMEAs (pFMEAs)., • Ability to interpret and react to leading quality indicators to drive preventive actions., • Experience supporting document control activities in a regulated environment., • Experience supporting test method validations and process validation activities, including protocol execution and data analysis., • Proficiency in performing or overseeing sample preparation and testing such as tensile, BFR, DSC, and chemical testing, with a strong focus on data integrity., • Experience leading inspection activities and making disposition decisions for manufactured products., • Ability to author and revise quality procedures and work instructions., • Experience conducting training, including onboarding of new employees and cross-functional personnel., • Associate degree or equivalent education., • Familiarity with ISO standards and FDA compliance requirements, including 21 CFR 820., • Experience in contract manufacturing of medical device components., • Strong analytical skills and a data-driven approach to problem-solving and decision-making., • Ability to collaborate effectively with cross-functional teams, including operations, engineering, and quality., • Strong written and verbal communication skills for documenting quality records, procedures, and training materials., • Demonstrated ability to mentor and coach junior technicians and operations personnel., • Continuous improvement mindset, with experience supporting or leading improvement projects. The Quality Engineering Technician works in a regulated manufacturing environment focused on the production of medical device components. The role involves frequent interaction with production areas, laboratories, and office settings, using test and measurement equipment for tensile, BFR, DSC, and chemical testing. Work is highly collaborative, involving close coordination with engineering, operations, and quality teams. The environment emphasizes adherence to documented procedures, calibration and validation requirements, and compliance with ISO standards and 21 CFR 820. Standard business hours typically apply, with additional time as needed to support production schedules, validation activities, and critical quality issues. Appropriate attire aligns with a professional manufacturing and laboratory setting, including any required personal protective equipment when working on the production floor or in testing ar Job Type & Location This is a Contract to Hire position based out of New Hartford, NY. Pay and Benefits The pay range for this position is $29.00 - $36.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program • Hiring diverse talent, • Maintaining an inclusive environment through persistent self-reflection, • Building a culture of care, engagement, and recognition with clear outcomes Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.