Systems Design Quality Engineer

8 Hours ago • 3-5 Years

Job Summary

Job Description

The Systems Design Quality Engineer ensures the quality, reliability, effectiveness, and safety of innovative products. Key responsibilities include guiding project teams on Quality Management Systems, product standards (IEC60335/IEC60601/21 CFR820/ISO13485, etc.), and driving quality and regulatory compliance. This involves creating quality deliverables, reviewing requirements management, ensuring proper risk management, and ensuring compliance with quality system requirements. You will work in project teams, coordinating with various teams and stakeholders. The role involves instructing, coaching, and facilitating project teams to ensure product quality and compliance with relevant standards and regulations.
Must have:
  • Bachelor's degree with 5+ years of related experience
  • Applied knowledge of global medical device regulations
Good to have:
  • Experience in the medical device industry
  • Ability to manage stakeholder needs effectively

Job Details

Job Title

Systems Design Quality Engineer

Job Description

The Systems Design Quality Engineer assures the quality, reliability, effectiveness and safety of innovative (medical and non-medical) products in a dynamic environment. Key challenges include risk management, design quality assurance activities, compliance with standards and regulations, resolving quality issues, driving continuous improvement and co-ordination of quality activities with engineering, procurement, manufacturing, clinical, service and support teams. Supports organization to work compliant in a lean way.

Your responsibilities 

  • Instruct, coach and facilitate project team’s w.r.t Quality Management System (Procedures/ Policies/ Guidelines/ tools/ training, etc.).
  • Instruct, coach and facilitate project teams on relevant product standards (IEC60335/IEC60601/21 CFR820/ISO13485, etc.)
  • Drives and supports quality & regulatory compliance to assure products & services comply with the Quality Management System / Business Management System requirements
  • Create quality function deliverables as per Innovation Site Eindhoven –Quality Management System in projects, in Life Cycle Management and in Post Market Surveillance.
  • Review Requirements Management process and outcome.
  • Reviews Product Verification and Validation.
  • Ensure Risk Management quality (quality of UFMEA, DFMEA, PFMEA/HB-SRA, etc.).
  • Ensure compliance to quality system requirements, regulations and standards in designated area of responsibility.
  • Ensures timely execution and required communications and escalation.

Your team

You will be part of the Q&R team consisting of approximately 30 team members working for the business unit Grooming & Beauty reporting to the Quality Group Lead. You will be based in Drachten, The Netherlands. You will work in project teams with co-ordination with marketing teams, manufacturing teams at various sites, supplier teams, and other Q&R members across Philips.

We are looking for

  • Bachelor degree with 5+ years of related experience or a Master degree with 3+ years of related experience.
  • Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001.
  • Preferably experience in a medical device industry.
  • Proven ability to successfully incorporate and manage stakeholder needs throughout a project
  • Communicate globally, across teams and programs, from senior executives to administrative support personnel. Experience leading remote teams.
  • Both detail oriented and able to see big picture

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 on our Philips Drachten site.

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About The Company

At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life.For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.Together, we deliver better care for more people because we believe that every human matters.

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