Quality Control Engineer

Job Description Job Description 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 : 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 SolidWorks, 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. The Following Qualifications May Aid in the Success of This Role : Bachelor's in Engineering, or related technical field. 3 years' experience in a regulated industry. 3 years experience in metal working. Knowledge of FDA, ISO 13485, 21 CFR Part 820 standards. CQE (Certified Quality Engineer) CQA (Certified Quality Auditor) Six Sigma Certifications ISO 13485 Lead Auditor 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 To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to -us / candidate-privacy The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and / or security clearance requirements, including, as applicable : The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for Employers San Francisco Fair Chance Ordinance Massachusetts Candidates Only : It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.