Director, Quality Assurance

Responsibilities:

1. Ensure compliant conduct per QSR, ISO, and corporate requirements as the designated management representative for the site.
2. Support the realization of new products through new product development, third party manufacturers, and/or mergers and acquisitions, including oversight of Design Controls.
3. Develop, communicate and build consensus for quality goals, objectives and programs that support business unit and company goals; identify and make recommendations for strategic direction within the site and/or business unit.
4. Prepare and maintain the departmental budget; effectively make decisions to utilize resources maintaining department budget while meeting department and business unit goals.
5. Develop site and/or organizational policies and authorizes their implementation.
6. Oversee the development, maintenance, and improvement of the Quality Management System, including promoting QMS harmonization across sites and identifying opportunities for improvement within the QMS and related systems.
7. Liaise with manufacturing as it relates to Quality, including internal audits, incoming materials and product distribution.
8. Partner with IT and QARA leadership to maintain and enhance the learning management system and other QMS systems as the administrator for the site.
9. Ensure appropriate QSR and ISO audits are performed for critical suppliers and service organizations; ensure proper quality agreements are maintained per Company procedures.
10. Attend QA Global One meetings to discuss global initiatives, challenges, etc.
11. Support cross-company projects and/or new product development as the site Quality contact between SMD (or other Subsidiary Companies).
12. Provide QA support and direction for contract manufactured products.
13. May lead Corrective and Preventative Action (CAPA) investigations and resolve potential product quality issues as they relate to compliance or continuous improvement.
14. Demonstrate commitment to the development, implementation and effectiveness of Company’s Quality Management System per ISO, FDA, and other regulatory agencies.
15. Understand and is aware of the quality consequences which may occur from the improper performance of their specific job.
16. Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
17. Carry out duties in compliance with established business policies.

Background Requirements:

1. Bachelor's degree in a scientific field; Advanced degree preferred.
2. 10+ years relevant work experience in IVD (reagent and/or instrumentation) industry or related experience preferred.
3. Managerial and lead auditor experience preferred.
4. Thorough knowledge of FDA QSR, ISO 13485, MDSAP, and Japanese requirements (Specific requirements, regulations, and directives are identified in Site Quality Manual and/or SOP’s and/or Policies).
5. Ability to create and maintain budgets.
6. Proficient with ERP and electronic QM systems.
7. Comfortable in a leadership role, including providing direction to directors and senior managers in various areas and/or groups.
8. Ability to consistently work with abstract ideas or situations across functional areas of the business; through assessment of intangible variables, identifies and evaluates fundamental issues providing strategy and direction for resolution of issues.
9. Exhibits professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

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