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Senior Production Quality Assurance Manager
2 weeks ago
About the Job
The Senior Production Quality Assurance Manager is responsible for ensuring the quality of both medical and non-medical products through rigorous inspections, implementation of quality control measures, and identification of areas for improvement. The ideal candidate will possess a strong background in engineering or quality assurance, attention to detail, a proactive mindset, and preferably experience in people management.
About You
We are seeking a highly skilled and experienced production quality assurance professional to join our team. The successful candidate will have a strong understanding of quality systems and processes, with excellent analytical, problem-solving skills, and knowledge of lean and investigation tools such as 8D and fishbone diagrams. Experience working in a manufacturing environment, particularly in the biomedical or medical device industry, is advantageous.
Key Responsibilities
* Address production quality issues by identifying problems and collaborating with cross-functional teams to develop solutions for overall product quality improvement.
* Utilize statistical tools to identify trends and patterns for enhancing the production process and ensuring quality.
* Investigate and correct root causes of product failures occurring in the field.
* Conduct periodic production audits to ensure compliance with established policies, procedures, and control plans.
* Participate in lean and continuous improvement initiatives, while adhering to company EHS requirements to prevent injuries and maintain safety.
Requirements
* Bachelor's degree in Biomedical, Mechatronics, Mechanical, Electronics or related engineering disciplines.
* At least 5 years of relevant Quality Assurance experience in manufacturing industry.
* Strong analytical, problem-solving skills, and knowledge of lean and investigation tools such as 8D and fishbone diagrams, with a solid understanding of engineering principles, theories, and concepts.
* Working experience in biomedical or medical device industry is advantageous.
* Proficient in statistical control methods and QMS 9001; familiarity with ISO13485, USFDA QSR/cGMP, and ISO14971 for medical devices is advantageous.
What We Offer
We offer a comprehensive benefits package that includes competitive salary, health insurance, retirement plan, paid time off, and opportunities for professional growth and development.
Join Our Team
We are a dynamic and innovative organization committed to delivering high-quality products and services. If you are a motivated and results-driven individual with a passion for quality and excellence, we encourage you to apply for this exciting opportunity.
