Championing product quality and reliability for IGT Systems by setting strategic targets, guiding cross-functional teams, and driving continuous improvement through field insights and expert engineering leadership.
In this role, you have the opportunity to
• Lead on setting Quality and Reliability targets for IGT Systems medical products so that these innovative products deliver high quality and outstanding reliability to the lives they will improve.
• Use your expert Quality and Reliability engineering skills to provide coaching and support to the project team(s) and assure that those targets are achieved. This involves being a confident advisor on quality and reliability engineering topics.
• Closely work with the post market teams to bring back the learnings from the fielded products (Installed base) and work with the R&D team to implement the design changes to fix the issues to make the products better.
You are responsible for
• In partnership with other functions, defining and managing the holistic patient and user safety, quality and reliability strategy and approach, overseeing execution and quality of results, driving to sufficient confidence in the product/service prior to release to market.
• Ensuring that appropriate Quality plans are made that include all stages of the products lifecycle and support Quality Plan design.
• Validating key design inputs like usability, reliability, performance, safety, quality and their related test strategies to ensure appropriate statistical confidence and reliability levels.
• Providing effective oversight on the execution of the Quality Plan and any risk management activities, and of all design related activities during the lifecycle of the product.
• Leading quality related problem solving.
• Ensuring that the post-market data on the products performance is effectively used to make required design/process improvements through close collaboration with the cross functional teams.
• Acting as a go-to subject matter expert for project team(s) and business functions to provide guidance on all Design Control processes in the product design and development. You are responsible to ensure the products design quality related requirements/criteria are complete and meet the Quality standards for every project milestone.
• Make substantial contribution to integrate requirements engineering/CTS/CTQ flow down activities with the medical device development activities.
Functie-eisen
Specific skill requirements for this role include:
• Bachelors engineering degree with 12+ years of experience / Masters degree with 8+ years of experience; preferably in Quality or Reliability Engineering role in the medical or aerospace industry.
• Additional R&D background and mindset with knowledge of product and software development processes would be desirable.
• Preferably, you have a DfSS Green Belt certification and are willing to further develop towards Black Belt certification.
• Experience in applying problem solving/root cause finding methodologies
• Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR, IEC60601, IEC62366 and ISO14971 would be a plus.
• Ability to define detailed Quality and Reliability plans for new medical product developments to ensure those are Safe, Effective and Reliable.
• Ability to lead Risk Management and FMEA activities for new products and assurance that control measures are translated into appropriate (critical) requirements.
• Strong exposure to application of Design Controls; ability to do thorough Design Reviews during new product development to ensure robust designs that further improve patient safety and product quality.
• Ability to partner with Verification & Validation teams to assure thorough Verification, Validation and Useability testing.
• Analyze development and field data for trends of Product Safety, Quality and Reliability performances and areas for further improvements of Product design and related development processes.
• Strong experience with Systems Engineering methodologies / tools.
• Experience with adequate and accurate review of DHF and DMR documents.
• Experience with working in multidisciplinary teams in a high-tech R&D environment.
• Ability and willingness to work at least 3 days in office.
Competenties
To succeed in this role, you should have the following skills and experience
We are looking for a leader, who leads by example, who continuously strives for excellence as a way of life, not just as a job. Were 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 for the billions of people Philips brand touches each year.
Furthermore to be successful in this role you are :
- Motivated, self-driven with a determination to succeed and the ability to adapt to change.
- Analytical, you are open to new ideas and believe in continuous learning in order to develop new competencies.
- You combine analytical and conceptual thinking, physical insight, flexibility and a hands-on mentality to deliver sustainable results and creative solutions;
- A critical but constructive business partner
- Customer focused, have excellent communication skills and you are a team player.
- Effective interpersonal, written and oral communication skills expected.
Arbeidsvoorwaarden
Primary employment conditions
- A monthly salary up to €6400
- A 13th month payment, pro-rated periodically
- 8.33% holiday allowance calculated on 12 monthly salaries
- Pension Plus scheme (build-up from day 1)
- 5% ADV allowance
- Net €750,- to set up your home workplace
- 25 vacation days per year based on 40 hours
- Travel allowance
- Internet allowance
- Home working allowance
Bedrijfsinformatie
You are a part of
You will be part of the global Philips Patient Safety & Quality organization and will be reporting within the Design Quality team for our IGT-Systems Business. As member of this team, you contribute to our constant strive for further product quality improvements, so we continuously exceed both internal and external stakeholder expectations.
About Phillips
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 the lives of others. As a leading health technology company, it is our purpose to improve people’s health and well-being through meaningful innovation. We aim to improve 2.5 billion lives per year by 2030.
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 transforming themselves personally and professionally.
Working at Philips is more than a job. It's an experience filled with unexpected 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.
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent.
contact
Amisha Kashyap
amisha.kashyap@yacht.nl
+918374294984
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