Quality Control Engineer

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Adecco
Watertown, CONNECTICUT, United States
  • Environmental
  • FlexTime
  • FullTime
  • Weekdays
  • Applications have closed

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 yearEqual Opportunity Employer/Veterans/DisabledTo read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://uat.adecco.com/en-us/candidate-privacyThe 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.

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