Quality Engineer

Job description

Job Title

Quality Engineer

Job Description

In this role, you have the opportunity to

guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.

You are responsible for

Provide QA resource to product support to ensure regulatory compliance of post market products.

•Assessing quality plans, assessing product designs and reviewing test and other performance data,

•Analyze market feedback & lead root cause analysis

•Ensure that projects to develop medical devices follow applicable company policies, procedures, standards and regulations.

•Ensure that released devices are safe and effective and meet their intended use.

•Assist in production and market of product in investigating and reporting the results of investigations for reported technical problems as part of corrective actions.

•Support the investigation of vigilance and reportable events and reporting of the results of the investigations to corporate and regulatory authorities.

•Travel to assist in customer, internal and supplier audits where required either in the UK or internationally.

•Manage auditing of internal and supplier quality systems to ensure effectiveness of the quality management system.

•Assist in improving the culture of all staff in Quality & Regulatory requirements of the Medical Device Requirements.

•Support the QARA Manager in quality and regulatory decisions as required and other relevant tasks as may be reasonably requested of the QARA Manager.

•Manage safety risks associated with medical devices in accordance with applicable standards.

•Facilitate usability analysis and activities in accordance with applicable standards.

•Represent QA on product defect review boards, and change control boards.

•Help coach project teams on use of quality system.

•Prepare for and participate in project and quality systems audits and inspections.

•Proactively participate in design reviews, quality business reviews and post market improvement teams.

•Support the worldwide regulatory requirements through product submission, registration and continued compliance through complete life cycle of medical devices.

•Assist in investigating and reporting the results of investigations for reported technical problems as part of corrective actions.

•Provide risk management and design control guidance for design quality assurance activities on medical device projects and coordinate quality activities with engineering, clinical, sourcing, manufacturing, distribution, service, and support teams.

•To support the worldwide regulatory requirements through product submission, registration and continued compliance through complete life cycle of medical devices.

•To provide regulatory and quality input for medical device products from generation through release to obsolescence assisting in planning, developing and quality support in projects.

•To support quality control requirements, supplier quality, complaints, post market support, audit, non-conforming materials, CAPA systems and process risk.

You are a part of

A professional team of Quality Engineers in Drachten

To succeed in this role, you should have the following skills and experience

A person who is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We're looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people Philips brand touches each year.

Desirable skill for this role include:

•Knowledge of 13485 / 9001 / FDA / Canada / 14971/ standards

•FMEA/ Root Cause Analysis/ Problem solving

•Interaction with different functional groups.

In return, we offer you

A path towards your most rewarding career. Succeeding in this Quality role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.

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 3 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 .

To find out more about what it's like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there, you can also learn about our recruitment process , or find answers to some of the frequently asked questions .

Contact

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