Job TitleLead Design Quality Assurance Engineer
In this role, you have the opportunity to
Support product development programs (new and sustaining) and provide regular coaching and mentoring to the local Design Quality Assurance team to ensure compliance.
Lead proactive design assurance activities facilitating the development and release of high quality products.
You are responsible for
- Integral member of product development team responsible for supporting activities required to ensure quality of the design through compliance with design controls
- Providing guidance of Design Controls and the Product Realization Process (PRP) to the project teams
- Supporting the establishment and maintenance of design and development plans in support of quality and compliance for program and project assigned
- Participating in the review of clinical relevant test methods, design verification test plans and results, and validation test plans and results
- Working with Program Managers on Risk management activities including supporting risk management activities and essential requirements analysis
- Supporting compliance assessments of the DHF and other program files to ensure quality and regulatory requirements are achieved and ensuring DHF completeness
- Participating in reviews related to design, validation, defect classification and documentation as required
- Supporting Post Market Product Assurance, audit group, and other business partners in post-market activities
You are a part of
CT/AMI Q&R Organization. in this role you'll provide technical expertise in the area of design assurance to Engineering, Operations, Customer Service, Field Service personnel and other business partners and work as part of a cross-functional, collaborative, global teams.
To succeed in this role, you should have the following skills and experience
- Bachelor's degree in engineering/science discipline or technical certification in related field
- 5+ years of experience in product design and development or related work experience
- Regulatory compliance awareness including design controls and risk management in a regulated industry
- Strong technical skills with demonstrated ability to provide solutions to a variety of technical problems of moderate scope and complexity
- Ability to learn quickly and respond to changing priorities
- Must have strong interpersonal communication skills as well as being a motivated team player
- Technical writing and presentation skills
- Good verbal and written communication skills, good team skills including project management
- Experienced with basic PC skills (MS Word, Excel, PowerPoint, and Project)
- Regulatory compliance awareness such as FDA design controls CFR 820, ISO 14971, ISO 13485, IEC60601, IEC62304 and similar - strong advantage
In return, we offer you
Endless opportunities to learn and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already.
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.
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