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.

Intermittent 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 8:00 a.m. – 4:30 p.m.). 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.

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• 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.
• Maintain thorough and accurate records of all testing procedures, results, and corrective actions to comply with regulatory audit requirements.
• Assist in internal and external audits by regulatory bodies, ensuring all processes meet the necessary compliance standards.
• Conduct risk assessments to identify potential hazards associated with the medical device and develop mitigation strategies.
• Perform Failure Modes and Effects Analysis (FMEA) to systematically evaluate and document potential failure points and their impact on patient safety.
• Identify and document non-conformances in product quality or processes.
• Conduct root cause analysis for non-conformances and implement corrective and preventive actions (CAPA) to address and prevent recurrence.
• Work closely with Manufacturing, supply chain, and engineering to ensure product quality from production to shipping.
• Provide training to team members and other departments on quality standards, testing procedures, and regulatory compliance.
• Create and review detailed test protocols that include objectives, methods, acceptance criteria, and statistical methods.
• Write and assist in executing test protocols, IQ, OQ, PQ including software validation.
• Utilize statistical tools and methods to analyze test results, ensuring the reliability and repeatability of the results.

• Proficiency in statistical analysis tools or statistical modules within software like Excel and Minitab for analyzing data, conducting statistical tests, and interpreting results.
• Strong skills in using tools like Microsoft Excel or Power BI for analyzing and visualizing quality-related data, trends, and key performance indicators (KPIs).
• Familiarity with QMS software platforms for managing and tracking quality processes, audits, corrective actions, and compliance.
• Knowledge of CAD software, such as AutoCAD or Solid Works, is valuable for quality engineers involved in design verification, tolerance analysis, and product inspection.
• Familiarity with document management systems for organizing, storing, and retrieving quality-related documents.
• Skills in using root cause analysis tools like Fishbone diagrams (Ishikawa), 5 Whys, or Fault Tree Analysis software to identify and address the root causes of quality issues.
• Knowledge of ERP systems such as SAP, Oracle ERP, or Microsoft Dynamics for integrating quality processes with broader business operations.
• Proficiency in project management tools for planning and tracking quality-related projects and initiatives.
• Proficiency in metrology software for measurement and inspection purposes.
• Knowledge of compliance and auditing tools to ensure adherence to industry standards and regulations.
• Skills in using risk management tools to assess, monitor, and mitigate risks.
• Familiarity with LMS platforms for creating, delivering, and tracking training programs related to quality standards and processes.

• Bachelor’s in Engineering or a related technical field.
• 3+ years’ experience in a regulated industry.
• 3+…