Job Description :
- Develop, change, and supervise Quality inspections to ensure the greatest value in quality control for the customer and the plant during the manufacturing process while meeting regulatory requirements.
- Process monitoring and adjustment, process improvement, and product improvement, including corrective action plans to address process / product issues.
- Documentation of activities, along with the review and maintenance of operating procedures as well as department-specific procedures.
- Develop, implement, and improve Quality procedures applicable to the manufacturing process for assigned product lines.
- Coordinate efforts with other Departments to establish controls and process capabilities for assigned product lines.
- Actively support and provide input for process validation, process acceptance, internal and external audits, and resulting corrective actions.
- Supervise the performance of assigned product lines regarding product quality, scrap, rejection rates, and other applicable metrics.
- Review and develop changes in existing or proposed processes or requirements to achieve optimum performance and cost.
- Assume a leadership role in analyzing and resolving process / product issues.
- Develop or improve test methods for inspection, including Test Method Validation.
- Monitor customer complaints and trends. Responding with specific corrective actions and customer interfacing as needed.
- Ensure that all company safety rules and regulations are followed and promote general plant safety.
- Develop / update and implement procedures to stay in sync with corporate and industry standards.
- Day-to-day supervision and coordination of QA Technicians.
- Other duties and projects, as assigned.
Education And / Or Experience :
Bachelor’s degree in engineering, and a minimum of four (4) years’ experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry Required,Master’s degree in engineering, and a minimum of two (2) years' experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent regulated industry.Preferred Qualifications :
Quality Engineering Certification (ASQ) or equivalentRequired Qualifications :
Ability to apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.).Sophisticated statistical and risk assessment techniques.