Job Title

Sr Design Quality Engineer

Job Description

DQE is responsible for the implementation of comprehensive process validation plans, ensuring smooth transitions of new products to production, working under general supervision. The role supports in the design control process, from validating design inputs to managing verification, validation, and design transfer, ensuring compliance with regulatory and quality standards. The role reviews and refines quality engineering documents, initiates quality improvement projects, and provides expertise in risk management. The role resolves complex quality issues, utilizes post-market analytics for continuous improvement, and prepares for quality audits to maintain adherence to internal and external standards.

In this role, you have the opportunity to

The Quality Engineer is accountable for oversight of system and hardware quality and risk management
throughout the product life cycle.
The Quality Engineer 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.
The Quality Engineer also provides analytics to the Business on the efficacy and efficiency of the design
and product realization processes

You are responsible to

Be responsible for the design control in Sustaining Project Quality Assurance
Ensures that appropriate Quality Plans are made that include all stages of the life cycle of the product
and supports Quality Plan design
Validates key design inputs like: usability, reliability, performance, supportability, manufacturability,
localizability, safety, security, privacy, serviceability, sustainability, and costs
Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and all
design-related activities during the product/system life cycle
Performs independent technical assessment of product quality performance and post-market product
quality analysis
Can Lead quality related problem-solving and root cause analysis during design and manufacturing
Uses post-market analytics and statistics to report on product quality performance in the field (provide
feedback to manufacturing, suppliers, or design teams) and initiates field actions when required
Act as a single point of contact (the person assigned to the project team) responsible for ensuring that
hardware design meets quality and compliance standards for every milestone
Ensure product-development processes and documentation meet Quality System requirements in
relevant regulations, e.g. CFR 820.30, and ISO13485.
Drive project decision direction toward compliance, cross-functionally and globally. (Process)
Ensure that program documentation (Design History File) is created, controlled, and archived per the
Quality System. (Process)
Lead, prepare, and participate/be the main escort in internal and external audits
Frequently interacts with supervisors and functional peer groups. Interaction normally requires the
ability to gain the cooperation of others, conducting presentations of technical information concerning
specific projects or schedules.

To succeed in this role, you should have the following background, basic skills or experience

BE in Engineering
Strong quality assurance management experience, minimum 8 years in quality assurance
Strong design control and new product development experience
Strong analytical abilities
Professional knowledge in the area of ISO 13485, FDA 820, ISO14971, FDA/MDR/MDSAP
Strong communication, problem-solving, and continuous improvement.
Fluent in English both in writing and speaking
Have experience in the medical industry or highly regulated industry (preferred)
Strong Influence Skills, Presentation Skills and Dispute solving Skills

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.

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.
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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 culture of impact with care .