Philips Quality Manager HPM Consumables Business 

United States, Ohio 

985799114

With a focus on excellence, you will play a pivotal role in delivering innovative and life-changing solutions to 2.5 billion patients around the world, improving their health and well-being.

Your role:

• As part of the Quality Operations Organization at Philips, your challenge will be to guide and support business partners and enabling functions with important decisions about patient safety and product quality. This involves being a confident advisor on approval for product quality, regulatory compliance and quality management related topics, in order to achieve timely shipment and releases of innovative products and processes that deliver high quality and outstanding reliability to the lives they will improve.

• You will lead a team of around five motivated professionals and will work with business partners from industrialization, supplier engineering and factory and warehouse management to achieve business goals while adhering to the highest standards in quality.

• Teaming up with counterparts from other Philips’ locations and stakeholders to exchange best practices and participate in onsite collaborative projects.

You're the right fit if:

• You’ve acquired 5+ years of engineering experience (preferably in the quality space) with process validation, NC handling, hold, environmental control, calibration, preventive maintenance, audit preparation, and QMS procedures.

• You have a master’s degree in a technical discipline and 5+ years of experience with medical devices or in another regulated industry.

• Your skills include the ability to positively influence your team and stakeholders to make the right decisions about patient safety and quality by acting as a cross-functional partner. Knowledge of regulations such as ISO13485, 21CFR Part 820, ISO14971 paired with pragmatism in application and execution is essential.

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

• You’re experienced with internal and external audits, follow-ups, and handling of non-conforming products combined with disposition activities and Corrective and Preventive Actions (CAPA). A lean, hands-on management style is crucial for success in this space. Experience working in an international environment is preferred.

How we work together

This is an onsite role.

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 improve the lives of others.

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The pay range for this position in Ohio is $84,000 to $134,400

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.