Job TitleDirector of Quality

Job Description

Your Role:

The Director of Quality has overall responsibility to formulate and implement the sites' long-range quality and compliance policy, and to lead and direct organizational development and process. Improvement in such a way as to ensure that the Business strategic policy and strategic growth targets are met. Also appointed to the role of US FDA Management Representative and as the China GSP medical device operating license ‘responsible person for Quality’.

In this role, you are responsible for:

Formulates and implements the sites' long-range quality and compliance policy. Creates Quality awareness level as determined within the organization. Enforces (simplified) quality systems and harmonizes them across the Business sitesEstablishes and maintains an effective Management Review process, including routine reporting. Introduces and implements the quality processes and tools required to ensure product quality and customer satisfaction. Manages compliance to FDA, China and other Regulatory Agencies regulations as required, ensuring guidelines and policies to all products and operations are consistent with those regulations. Manages the review and approval of finished products manufactured for and by the company in accordance with their approved specifications. Manages all internal and external quality and regulatory inspections and questions relating to the site’s quality system in coordination with all other applicable company groups. Manages product recall activities to include recall policies and procedures for the company.Manages product complaint activities and processes and maintains overall responsibility for products in scope of the local QMS. Drafts and manages the strategic improvement processes and transformational programs in the Quality domainInteracts with all areas involved in the product development process, operations, customer services and sales and marketing and provide direction and consultation. Ensures that all products to be released comply with all the relevant safety and environmental policies and regulations by implementing requirements, conditions and enablers in the Business. Participates with peers and other senior managers to establish strategic plans and objectives. Makes final decisions on administrative or operational matters and ensures the effective achievement of the company's business objectives in full quality and regulatory compliance. In the role of Management Representative, to ensure management review meetings are held as required to assess the continuing suitability and effectiveness of the QMS and that adequate records of such reviews are maintained.  Act as Person Responsible for Regulatory Compliance for assigned responsibilities. Act as the China GSP Responsible Person for Quality

You're the right fit if you have a customer-first attitude, motivation for change, and the following:

Bachelors’ degree required in medical device related majors (related majors refer to medical devices, biomedical engineering, machinery, electronics, medicine, biological engineering, chemistry, pharmacy, nursing, rehabilitation, laboratory science, computer, law, management, etc.)Master's or PhD degree preferred. Shall have more than 3 years of medical device business quality management experience. Typically requires a minimum of 7 years of related experience Has broad expertise or unique knowledge, uses skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways. The most senior level individual contributor manager. Having broad expertise or unique knowledge, uses skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways. Has complete knowledge of all company products and services. 

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

Indicate if this role is an office/field/onsite role.

About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.