Sr. Quality Assurance Manager
In this role, you have the opportunity to
- Plan and execute the quality management system related activities and support innovation teams on the site.
You are responsible for
- Formulate and implement the Business’ long-range quality and compliance policy.
- Create Quality awareness level as determined within the organization.
- Enforce (a simplified) quality systems and harmonize them across the Businesses and Cluster sites; establish an effective Management Review process, including routine reporting.
- Lead the Philips QMS (PQMS) related deployments and implementations.
- Ensure the addition and management of any local QMS documents in line with the evolution of the PQMS.
- Manage site training Matrix and training assignments.
- Ensure training and training registration as per the QMS and generates training content for local QMS processes as necessary.
- Manage and facilitate the CAPA process and the audits on the site
- Support Documentation & Change control process
- Introduce and implement the quality processes and tools required to ensure product quality and customer satisfaction.
- Manage compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations.
- Manage the review and approval of finished products manufactured for and by the company in accordance with their approved specifications. Includes Complaint handling.
- Manages all inspections and questions relating to the operation of the manufacturing sites in coordination with all other applicable company groups.
- Manage product recall activities to include recall policies and procedures for the company. Additionally, manage product-compliant activities and processes.
- Direct the Audit Program for the organization.
- Draft and manage the strategic improvement processes (‘breakthrough Program’) in the Business (One Page Strategy, Hoshin Plan).
- Interact with all areas involved in the product development process, customer services and sales and marketing and provide direction and consultation.
- Support on the L4L and L4G initiatives for involved businesses.
You are part of
- The Philips business group Personal Health which delivers innovative lifestyle solutions for personal well-being. Our brand promise delivers innovation that matters to you, meaning that our products are caring, innovative & impactful.
- The global QMS team and reports to QMS Lead in Eindhoven.
To succeed in this role, you should have the following skills and experience
- Bachelor’s degree or above, major in Engineering related discipline is preferred
- Solid experience (10 years+) working in quality related functions, experience in MNCs/Medical industry is preferred
- Strong experience with ISO 9001, ISO 13485, CFDA,
- Understanding and application of appropriate global medical device regulations, requirements and standards, including FDA’s 21 CFR 820, EU Medical Device Directive (93/42/EEC), European Medical Device Regulation MDR 2017/745, ISO 13485, and MDSAP (including all member countries regulations).
- Ability to interact professionally with all organizational levels
- Must be results-driven - Able to manage competing priorities in a fast-paced environment
- Ability to communicate ideas and information clearly, effectively, and concisely
- Highly detailed oriented with strong organization and prioritization skills
- Good command of English and Chinese language skills required
Why should you join Philips?
- Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 2.5 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.
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Over 125 years ago, Frederik and Gerard Philips started a small light bulb company in Eindhoven.
Little did they realize that it would become a global force of innovation, committed to
improving billions of lives worldwide. But it did.
Today, Philips is a world leading health technology company with a vision to make life better
for people worldwide through meaningful innovation. Making good on this promise depends on our
passionate, inspirational, collaborative and diverse team.
We have over 80,000+ brilliant people around the world but are always looking for more.
Like-minded, motivated, focused minds to join us in creating a healthier, more connected society
while tranforming themselves personally and professionally.
Working at Philips is more than a job. It's an experience filled with unexcepted moments that
will transform you in lasting and positive ways. Help us improve the world for the better while
building a career that no one could have planned for. Even you.