ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
1. A seasoned manager with a solid track record of directing and motivating the quality team providing innovative ideas that get results.
2. Create and maintain quality systems that ensure success to our goal of 99% CFQ.
3. Develop and analyze statistical data and product specifications to determine standards and to establish quality and reliability expectancy of finished products.
4. Provide technical and statistical expertise to teams.
5. Formulate, document and maintain quality control standards and on-going quality control objectives.
6. Coordinate objectives with production procedures in cooperation with other plant managers to maximize product reliability and minimize costs.
7. Create, document and implement inspection criteria and procedures.
8. Interpret quality control philosophy to key personnel within Company.
9. Provide, and oversee, inspection activity for product throughout production cycle.
10. Apply total quality management tools and approaches to analytical and reporting processes.
11. Interact with vendors to ensure quality of all purchased parts.
12. Review designs to determine accuracy of information relating to quality requirements and translate them to inspection data.
13. Monitors and analyzes non-conformances to identify products or processes requiring quality improvements.
14. Design, develop and implement quality control training programs.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE:
Bachelor’s degree in related discipline and seven (7) years related work experience or equivalent combination of education and experience. Five (5) or more years of relevant quality system experience with a medical device manufacturer, and experience with ISO/CE certification. Quality certification preferred (e.g. CQE, CRE, CQM, Six Sigma, etc.). Practical CMM experience desirable.
OTHER SKILLS and ABILITIES: Strong communication and organization skills with the ability to prioritize and meet deadlines for multiple projects.
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