CMM Programmer
Listed on 2026-01-02
-
Engineering
Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Job Title:
CMM Programmer – Watertown, CT
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.
Responsibilities- Ensure that all testing processes and product developments comply with relevant medical device regulations such as FDA (21 CFR Part 820) and other international standards.
- CMM programming – Pc-Dmis.
- 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 R&D, Regulatory Affairs, Manufacturing, and Clinical teams to ensure product quality throughout the development process.
- 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.
- Execute test protocols, including software validation, biocompatibility testing, electrical safety testing, and sterilization validation, depending on the device, component, or assembly.
- Utilize statistical tools and methods to analyze test results, ensuring the reliability and repeatability of the results.
- Quality engineering
- Quality assurance
- Audit
- Medical device expertise
- CMM programming
- GD&T
- Statistical analysis
- Root cause analysis
- Quality management systems
- Corrective action plans
- PFMEA
Skills & Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or related field.
- 3 years’ experience in validation or quality in a regulated industry.
- PC-Dmis programming
- Knowledge of FDA and 21 CFR Part 820 standards.
- Certified Quality Engineer (CQE)
- Six Sigma Certifications
- Lead Auditor certification
Permanent position based out of Watertown, CT.
Pay and BenefitsThe pay range for this position is $80,000.00 – $/yr.
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