Mechanical Designer - Quality Process Lead

Mechanical Designer-QPL

Job Title

Mechanical Designer-QPL

Job Description

The Mechanical Designer-QPL 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 5 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.
• 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 culture of impact with care here.