ATL is looking to hire a Vice President of Quality and Regulatory Compliance to fill a newly created position. The ideal candidate will become an influential member of the ATL Executive Leadership Team and will be responsible to establish the vision, strategies and ultimately the tactics to deliver Quality Control & Quality Assurance activities, oversee the Quality Management Systems (QMS), and assure compliance to USA FDA cGMP Regulations across the global business. This individual will be leading the activities to develop the culture, policies and processes for Quality Assurance and Regulatory Compliance with current and future company locations worldwide including those presently operating in Springville Utah, Taipei Taiwan, Dong Guan China, and Costa Rica. The successful candidate will be expected to interact effectively with all levels of the corporation and customer base and will extract and transform data to support breakthrough improvement activities within the business.
The incumbent will have the ability to travel to all the ATL facilities internationally and domestically to interface with associates, suppliers and customers in this rapidly growing Contract Designer & Contract Manufacturer of interconnects & medical devices space. The work environment will be a typical multi-site office environment and the candidate will spend up to 25% of time traveling. It will be key to be actively involved with all ATL facilities, as well as customer and supplier factory processes to help improve design & manufacturing quality operations and guide resolution of issues.
Principal Duties and Responsibilities: Quality Assurance, Quality Management Systems, and Regulatory Compliance:
Establish the cohesive vision aligned within the company business model, strategies and tactics to mature and improve the Quality Assurance and Quality Control activities with supporting Quality Management Systems (QMS) that demonstrate continuous improvement and compliance to ISO standards and FDA regulations (cGMP) for core functions and sites.
Manage the corporate QMS metrics, CAPA and Internal Audit processes including formal, effective and detailed reviews to assure the business makes progress in problem solving with verification of corrections and tracking of results and detect & control emerging issues.
Oversee Management Review process and annual review activities including assigning the Management Representatives across the business.
Leadership and Organization:
Responsible for inspiring, mentoring, delivering career guidance, and building meaningful and lasting professional subordinate relationships to positively influence the direction of the company.
Oversee QMS qualifications, support hosting on site audits, drive timely and acceptable creation of verification & corrective action results with customers as appropriate.
Assess & Coordinate QMS alignment & improvement activities across locations to assure efficient execution of compliance to ISO13485, ISO9001, ISO 14001, and USA FDA CFR part 820 cGMP.
Develop and nurture a 3 5 year cohesive scalable vision of the department within the corporation supporting the detailed development and subsequent strategic plans supported by justification of department budgets and application of effective fiscal management to the approved budgets.
Constructive conflict resolution and Communication:
Demonstrated critical thinking capability and executive decision making with communications commensurate with audience
Ability to apply Lean Principles in the organization including describing the current state of a complex integrated organization and proposing re-engineering scalable processes including outlining the talent needed to bring the organization thru breakthrough to the future desired state.
Required skills, education and experience:
BS in a technical / scientific discipline such as BSME, BSEE, Physics, biology or similar technical degree to support technical exchanges with colleagues and customers.
12 years of progressive experience with clear understanding of the elements of ISO 13485 QMS processes, USA FDA part 820 regulations.
Experience overseeing the preparation for and hosting of an FDA Inspection including successfully resolving Warning Letters/483s.
Certification through nationally recognized associations such as ASQ or RAPS a plus.
Must be able to legally obtain business travel documents to China, Costa Rica, and countries that key customers reside within.
Internal Number: 1151791
About ATL Technology LLC
ATL Technology is an engineering and manufacturing company that creates custom disposable medical cables and devices, custom connector solutions and assemblies, and turnkey ODM/OEM products.