At Cadence, we improve product performance by building solution-oriented partnerships with our customers and delivering highly technical, measurable outcomes across medical, life sciences, automotive, and other advanced industries.
We’re an engineering company at heart—with over 75 engineers across our organization—and have built a legacy of over three decades of manufacturing excellence by doing what others consider impossible.

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). 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.

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.
• Skills in using tools like Microsoft Excel, Tableau, 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.
• Understanding CAM software, like CNC programming tools, is essential for quality engineers working in manufacturing environments to ensure alignment between design and production.
• Proficiency in test automation tools to automate repetitive testing tasks and improve efficiency.
• Understanding database management systems.
• 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.

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 R&D, Regulatory Affairs, Manufacturing, and Clinical teams to ensure product quality throughout the development process.
• 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: Execute test protocols, including software validation, biocompatibility testing, electrical safety testing, and sterilization validation, depending on the device, component or assembly.
• Statistical Analysis: Utilize statistical tools and methods to analyze test results, ensuring the reliability and repeatability of the results.

THE FOLLOWING QUALIFICATIONS MAY AID IN THE SUCCESS OF THIS ROLE:

• Bachelor’s in Engineering, Life Sciences, or related field.
• 3+ years’ experience in validation or quality in a regulated industry.
• Knowledge of FDA, ISO 13485, 21 CFR Part 820 standards.
• CQE (Certified Quality Engineer)
• Six Sigma Certifications
• ISO 13485 Lead Auditor