1. Adheres Integer Values and all safety and quality requirements including, but not limited to: Quality
Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
2. Supervises and directs day-to-day activities of Quality Assurance Engineers and/or Quality Technicians
3. Coordinates continuous improvement activities that help achieve site Gs&Os through the use of Lean Manufacturing and Six Sigma methodologies.
4. Supports Operations in the timely resolution of non-conforming materials.
5. Independently leads cross-functional teams to a timely and effective completion of agreed upon project goals.
6. Acts as a liaison with individuals and units within or outside his/her organization with responsibility for acting independently on technical matters pertaining to his/her field.
7. Supervises Associates in a manner that fosters a safe work environment and a self-directed team approach.
8. Facilitates communication, coordination and conflict resolution within and among work groups.
9. Provides leadership to Associates in all areas including: hiring, performance management, coaching, training and corrective actions.
10. Reviews and approves engineering change requests, nonconformance reports and engineering reports.
11. Supports the development of improved detection and error proofing techniques.
12. Supports resolution of customer complaints and quality corrective actions through guidance of engineering staff.
13. Drives appropriate level of process control using a risk based approach.
14. Acts as plant back up for Senior Manager, Quality as needed.
15. Performs others functions as required.
Minimum Education: Bachelor's degree in engineering or a related field required.
3-5 years of QA/QC engineering and supervisory experience in a manufacturing environment; medical device experience preferred.
Six Sigma Black Belt or equivalent preferred. Specialized knowledge needed for performance of job: ISO 13485, ISO 9001:2008 or equivalent required. Good Manufacturing Practices, Good Documentation Practices. Auditing training and experience.
Ability to lead team activities and represent the Quality function. Strong written and verbal communication skills. Ability to effectively work with all levels of the organization.
Quality mindset applied to all activities. Detail and results oriented. Geometric Dimensioning and Tolerancing, gauging, and inspection methods. Control plans and PFMEA experience.