Quality Control Engineer

Adecco is assisting a local customer who is currently seeking a Quality Control Engineer. They are an engineering company at heart-with over 75 engineers across their organization-and have built a legacy of over three decades of manufacturing excellence by doing what others consider impossible.

The hours are 8 : 00 a.m. - 4 : 30 p.m.. The rate of pay is $90K - $120K. Intermitent travel from Watertown to site in Suffield (as needed).

Position Overview :

We are seeking a highly motivated Quality Engineer onsite at our Watertown, CT site, to lead and support quality activities across multiple projects at our facility (Monday-Friday 8 : 00am -4 : 30pm). Flexible based on WT schedule This specialized role requires a focus on regulatory compliance, rigorous testing procedures, and meticulous documentation to ensure that relevant products are safe, effective, and meet all relevant standards before reaching customers.Apply online to : adecco.com.

Key Responsibilities :

• Adherence to Regulations : Ensure that all testing processes and product developments comply with relevant medical device regulations such as FDA (21 CFR Part 820), ISO 13485, and other international standards.
• Documentation and Record Keeping : Maintain thorough and accurate records of all testing procedures, results, and corrective actions to comply with regulatory audit requirements.
• Audit Participation : Assist in internal and external audits by regulatory bodies, ensuring all processes meet the necessary compliance standards.
• Risk Assessment : Conduct risk assessments to identify potential hazards associated with the medical device and develop mitigation strategies.
• FMEA : Perform Failure Modes and Effects Analysis (FMEA) to systematically evaluate and document potential failure points and their impact on patient safety
• Identify Non-Conformances : Identify and document non-conformances in product quality or processes.
• Root Cause Analysis : Conduct root cause analysis for non-conformances and implement corrective and preventive actions (CAPA) to address and prevent recurrence.
• Interdisciplinary Communication : Work closely with Manufacturing, supply chain and engineering to ensure product quality from production to shipping.
• Training : Provide training to team members and other departments on quality standards, testing procedures, and regulatory compliance.
• Develop Test Protocols : Create and review detailed test protocols that include objective, methods, acceptance criteria, and statistical methods.
• Perform testing : Write and assist in executing test protocol, IQ, OQ, PQ including software validation.
• Statistical Analysis : Utilize statistical tools and methods to analyze test results, ensuring the reliability and repeatability of the results.

Computer Skills :

The Following Qualifications May Aid in the Success of This Role :

Work Environment :

Split between office and production floor. Requires clear communication, computer use, and occasional physical movement around facility.

Pay Details : $90.00 to $120.00 per year

Equal Opportunity Employer / Veterans / Disabled

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