SR Design Quality Engineer

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.
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 completed in Engineering, Science or equivalent.

• Minimum 4 years of experience in areas such as Quality Engineering, Safety Engineering, R&D Engineering;

• You have experience with Design Controls, Design in Quality areas and global medical device regulations, requirements, and standards such as 21 CFR Parts 820, 803, 806, and ISO13485, ISO 14971, and ISO9001.

• Advanced/Fluent English Level.

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.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
This role is an office role/Administrative Shift
About Philips

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.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
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.