Design Quality Engineer
In this role, you will have the opportunity to:
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.
You will be responsible for:
• 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.
• Manage safety risks associated with medical devices in accordance with IEC 14971:2012.
• Manage post-release safety risks associated with complaints and returns.
• Facilitate usability analysis and activities in accordance with IEC 62366.
• 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.
• Facilitate analysis and activities associated with corporate privacy and security procedures
• 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
To succeed in this role, you should have the following skills and experience:
• Expertise in FDA’s 21 CFR 820/ISO 13485/14971/62304 standards
• Familiarity with IEC 60601 series of Medical Equipment Safety Standards.
• Familiarity with Problem solving, Investigations, Root Cause Analysis, Data analysis, Six-Sigma, Process control, failure modes effect analysis (FMEA) and other quality tools and techniques.
You will be a part of:
You will be part of the Sleep & Respiratory Care Quality Engineering, Systems and Hardware team.
In return, we offer you:
The opportunity to join a world class team that is helping to improve the lives of people everyday through the development of innovative medical device products.
Why work on a project at Philips?
If you’re looking for meaningful work and a chance to tackle complex challenges, broaden your skills and expertise and become an even more sought after professional, you’ll find all that and more with project work at Philips.
The Randstad companies are responsible for finding talent to provide services at Philips. If you are selected to provide services for Philips, you will be employed by Randstad and will not be an employee of Philips.