This position is responsible for managing quality assurance, test and document control functions within the respective manufacturing facility. This position must maintain compliance to all global Quality requirements. Responsible for implementing quality improvements.
1. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and processes and procedures.
2. May function as Management Representative Designee, if appointed, for respective manufacturing facility, with responsibilities as defined in the facility's Quality Manual.
3. Oversee all aspects of quality control and quality assurance including conformance of products and processes to global standards as applicable, assessment and improvement of the quality system, change control approval, and management of the internal auditing program.
4. May have management responsibility or the CAPA system, as designated.
5. Participate in the development of the Company's policies, goals, and programs including preparation and communication of overall goals for the department.
6. Provide guidance and leadership to the site on Design Control, specifically Design Validation and Reliability.
7. Report the performance and project status of the Quality programs and functions to Management.
8. Interface with other functions to analyze data and provide solutions for quality issues.
9. Manage and control material/product stored in Quarantine areas.
10. Manage and control non-conforming materials and overall events related to non-conformances (internal quality issues, external field issues), as needed for site.
11. Maintain current knowledge of global medical device regulations pertaining to Design Control, Product Realization, Risk Management and Reliability. Act as resource to other departments, participate in decision-making concerning policies, requirements and strategies, and manage external consultants as needed.
12. Utilizes the systems and processes in place to attract, develop, engage, train and retain talented Associates: creating a work environment where Associates can realize their full potential, thus allowing the organization to meet business needs.
13. Perform other duties as assigned.
Requires a four year college degree in and a minimum of eight years of experience working in quality assurance or related capacity in a regulated medical device, manufacturing, biotech, or pharmaceutical environment, of which a minimum of two years must be supervisory experience. Intermediate computer software skills, i.e. Microsoft Office. Master's degree preferred. Certification from ASQ, CQE, etc. preferred.