Description
General Functions- Formulates procedures, specifications, and standards for products and processes.
- Provides leadership for quality engineering projects from concept through design, implementation, testing, documentation, support, and maintenance.
- Develops and implements corrective/preventative action plans.
- Collects and analyzes data for gauge and product evaluation.
- Develop and maintain an effective and robust quality system which complies with all relevant regulatory requirements.
- Ensure all validation activity is effective and documented in a compliant manner.
- Complete in-depth investigations into customer complaints and implement corrective and preventative actions, as appropriate.
- Identifies critical personnel, gauges, procedures, and materials needed for the completion of new products.
- Ensures that suppliers have necessary information and facilities to deliver quality products
Skill Requirements -
- Process Validation and Risk Assessment.
- Expert knowledge of blueprint reading and geometric dimensioning and tolerancing.
- Understanding of QSR/ISO regulations
- Design assurance, FMEA, and product testing methods, and able to use optical comparators and CMMs.
- Knowledge of statistics, process control, and process capability.
- Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
- Facilitates team efforts on quality engineering projects.
- Ability to deliver, meet deadlines and have results orientation.
- Able to communicate both orally and in written form to multiple levels of the company.
Education / Experience
- Bachelor's degree in engineering is required or an alternative Bachelor's degree with certification as a Quality Engineer.
- Must be familiar with Microsoft Office Suite
- Accredited certification as a Lead Auditor
- Must have minimum of 5 years of experience in Quality Engineering field