Quality Engineer Products and Systems in Drachten, Netherlands

Guarantee the High quality and Security of Progressive (Medical and Non-Medical) merchandise in a Dynamic Setting. Key challenges embody danger administration, design high quality assurance actions and co-ordination of high quality actions with Engineering, Procurement, Manufacturing, Provide High quality, Medical, Service and Help groups. You’ll help the group to be compliant in a lean means.

Managing/supporting the actions for the design modifications (MLD -Modify Launched Gadget) and sustaining actions particular to the product household in alignment with high quality and compliance requirements

Your function:

• Main high quality associated downside fixing and root trigger evaluation throughout modification of design and manufacturing to drive and provoke enhancements in new/present undertaking, based mostly on learnings/ suggestions from earlier tasks/ market (each Security and High quality suggestions)

• Utilizing post-market analytics and statistics to report on product high quality efficiency within the area and provoke area actions when required

• Reporting developments to determine steady enchancment alternatives and product/course of enhancements.

• Ensures that processes for specifying and executing area high quality evaluation actions are sufficient to make sure the expectations of all key stakeholders are met.

• Delivering key paperwork comparable to numerous Submit Market Surveillance reviews and facilitates periodic Submit Market Surveillance Critiques, making certain PMS plans are made that embody all phases of the life cycle of the product and helps High quality Plan design

• Supporting complainant as wanted to observe up on and resolve the criticism when wanted

• Instructing, teaching and facilitating undertaking groups with regard to High quality Administration System (Procedures/ Insurance policies/ Pointers/ instruments, and so forth.), making certain compliance to high quality system necessities, laws and requirements within the designated space of accountability

• Guaranteeing common communication on high quality standing, compliance standing, area name fee all through the undertaking execution inside the undertaking crew and stakeholders

• Main all product security/compliance associated actions to make sure that the laws and insurance policies are absolutely and well timed out there and interpreted, merchandise adjust to all regulatory necessities and Philips insurance policies and incidents are dealt with in line with corresponding product security/compliance incident dealing with course of (together with overview and resolution making on product security/compliance associated escalations)

• Guaranteeing Threat Administration high quality (high quality of UFMEA, DFMEA, PFMEA/HB-SRA, and so forth.)

You might be part of

A crew of passionate and pushed professionals underneath the enterprise of Grooming & Magnificence and reporting to the Enterprise PMS Lead.

You are the best match if

• Bachelor’s and/or Masters diploma in an engineering self-discipline

• Sturdy expertise in High quality

• Earlier expertise in Medical machine and or relevant shopper product is most well-liked

• Fingers-on expertise and information in understanding of worldwide medical machine laws, necessities, and requirements, comparable to 21 CFR Components 803, 806, and 820, ISO 13485, and ISO9001, Medical Units Directive (93/42/EEC, 98/79/EC)) and EU MDR

• Downside fixing and failure evaluation expertise and analytical considering

• Self-motivated and a very good crew participant with the flexibility to work inside a cross useful group

About Philips

We’re a well being expertise firm. We constructed our complete firm across the perception that each human issues, and we cannot cease till everyone in every single place has entry to the standard healthcare that all of us deserve. Do the work of your life to assist the lives of others.

• Be taught extra about our enterprise.

• Uncover our wealthy and thrilling historical past.

• Be taught extra about our goal.

For those who’re on this function and have many, however not all, of the experiences wanted, we encourage you to use. You should still be the best candidate for this or different alternatives at Philips. Be taught extra about our dedication to variety and inclusion right here.

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