JOB SUMMARY: Position is responsible for supporting quality assurance and statistical process control in manufacturing and new product development with hands-on approach as a team member throughout all phases of projects, FDA and ISO regulated.
1. Develops and initiates standards and methods for inspection, testing, and evaluation.
2. Plans and conducts the analysis, inspection, design, test, and/or integration to assure the quality of the assigned product or component.
3. Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.
4. Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
5. Documents data obtained during all quality activities consistent with company policies and procedures.
6. Develops gauging applicable to products and tolerance.
7. Initiates corrective and preventive action (CAPA) plans with root cause analyses.
8. Communicates significant issues or developments identified during quality activities and provides recommended process improvements to management.
9. Develops quality plans as needed.
10. Directs technical and administrative workers engaged in quality activities.
11. Maintains a working knowledge of government and industry quality codes and standards.
12. Performs related duties as required.
JOB SPECIFICATIONS: Requires the ability to
SKILLS AND ABILITIES: Knowledge and skills identified are typically acquired by completing a Bachelors degree (BS) or higher and 3-years experience in medical product quality assurance. Must have a working knowledge of statistical sampling, blueprint reading, gauging concepts, and geometrical dimensions and tolerance. Must also have a working knowledge of FDA/ISO regulations as they relate to medical devices. Certifications preferred; CQE, Six Sigma, and Lean Manufacturing.
- Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
- Ability to effectively present information to Team Members with an emphasis on training.
- Ability to comprehend and apply principles of advanced calculus, modern algebra, and advanced statistical theory.
- Ability to work with concepts such as limits, rings, quadratic and differential equations, and proofs of theorems.
- Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, factor analysis and statistical process control.