Sustaining Design Quality Engineer
The Quality Engineer is accountable for oversight of system and hardware quality and risk management throughout the product life cycle. Provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met. Give analytics to the Business on the efficacy and efficiency of the design and product realization processes
Your role:
Provide Sustaining Design Assurance Quality Engineering support to sustaining (MLD) projects including design changes, supplier changes, process changes, etc. while embracing and upholding Patient Safety and Quality as highest priority.
Provide support to teams in resolving issues and technical challenges for commercialized products - including field issues, manufacturing issues, supply-chain-driven issues, etc. Support investigations and data analysis.
Create Issue Impact Assessments (IIA's) to analyze and document risk assessment per established procedures and with cross-functional team input.
Ensure that teams pro-actively incorporate effective QMS compliance planning within their project plans. Work with teams to ensure that applicable activities are planned, executed, and documented in an efficient, QMS compliant manner.
Ensure that all required Risk Management processes and activities are followed and appropriately documented.
Provide support to CAPA's, complaint analysis and trending, Design and Technical reviews, etc. as assigned.
You're the right fit if:
You have a Bachelor’s degree in biomedical engineering, mechanical or electrical engineering, or related technical degree with 3+ years of experience; OR bachelor’s degree with 3+ years of experience in a medical device or regulated industry.
You have experience with CAPA process, risk assessments, as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 820, 803, 806, and ISO13485, ISO 14971, and ISO9001.
About Philips
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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.