Senior Quality Assurance Engineer
4 days ago
We are seeking a highly skilled Senior Quality Assurance Engineer to join our team in the medical device industry. As a key member of our quality assurance department, you will be responsible for ensuring top-quality standards through expertise in plastic injection molding, metrology, and statistical analysis.
About the Role:- Quality Control & Assurance:Develop and maintain quality control plans for injection molding processes, conduct thorough inspections, investigate issues using root cause analysis, and implement corrective actions. Perform regular audits to ensure compliance with medical standards.
- Metrology & Measurement:Use advanced tools like CMM, laser scanners, and micrometers for precision measurement. Calibrate equipment, execute measurement plans, and analyze complex data to validate part dimensions and tolerances.
- Statistical Analysis:Apply statistical methods (SPC, DOE) to assess data, identify trends, and recommend improvements. Monitor quality metrics, generate reports, and advise stakeholders based on data insights.
- Regulatory Compliance:Ensure compliance with medical device regulations (FDA, ISO 13485). Prepare documentation for audits and stay updated on regulatory changes to integrate into quality practices.
- Education:Bachelor's degree in Mechanical Engineering, Industrial Engineering, Statistics, or a related field; Six Sigma or ASQ certification preferred.
- Experience:5-7 years in quality engineering, with specific experience in injection molding, metrology, and statistical analysis, preferably in the medical device industry.
- Skills:
- Proficiency in metrological tools (CMM, calipers, micrometers)
- Knowledge of plastic injection molding processes and requirements
- Strong grasp of statistical analysis tools (SPC, DOE)
- Familiarity with FDA and ISO 13485 standards
- Excellent analytical, problem-solving, and communication skills
The estimated salary for this position is $90,000 - $110,000 per year, depending on experience. Our company offers a comprehensive benefits package, including health insurance, retirement plan, and paid time off.
Work Environment:This is a full-time position in an office and manufacturing environment. Occasional travel may be required. Compliance with safety and industry regulations is essential.
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