Cadence, Inc. ยท 1 day ago
Quality Assurance Engineer
Watertown, CT
Full-time
Onsite
Mid Level
3+ years expCadence, Inc. is an engineering company focused on improving product performance across various advanced industries. The Quality Assurance Engineer will lead and support quality activities, ensuring compliance with medical device regulations and conducting rigorous testing procedures to deliver safe and effective products.
Industrial ManufacturingManufacturingMedical DeviceSupply Chain Management
Responsibilities
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 objective, methods, acceptance criteria, and statistical methods
Write and assist in executing test protocol, IQ, OQ, PQ including software validation
Utilize statistical tools and methods to analyze test results, ensuring the reliability and repeatability of the results
Qualification
Required
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 objective, methods, acceptance criteria, and statistical methods
Write and assist in executing test protocol, 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 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
Preferred
Bachelor's in Engineering, or related technical field
PC-DMIS programming experience
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
Company
Cadence, Inc.
Cadence is a contract manufacturer that fabricates razor-sharp custom-made cutting blades for medical device and diagnostics companies.
501-1000 employees
H1B Sponsorship
Cadence, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2018-04-18Acquired
Leadership Team
Rob Werge
President and CEO
Ken Cleveland
CFO
Company data provided by crunchbase