Job title:
Design Quality Engineer
Your role:
Cultivates effective relationships, shares knowledge, provides influence over projects and peer groups, demonstrating full understanding of area of specialization, and possesses working knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, and ISO 9001.
Validates key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs.
Possesses knowledge of design principles for complex, durable, electro-mechanical medical devices.
Independently produces quality engineering documents, coordinates quality plan design for hardware/software and system design, and supports stakeholders during the execution of quality system, product audits, and inspections.
Executes assessment of product and system designs, reviews of test and other performance data, analysis of market feedback, carrying root cause analysis, quality problem solving, and addressing quality engineering deficiencies to embed quality in design.
Works under limited supervision, leads improvement projects, initiating change, and ensures that appropriate quality, reliability, and Post Market Surveillance (PMS) plans are included in all stages of the product life cycle.
Provides effective oversight of execution of quality, reliability, PMS Plans, Risk Management activities, and all design related activities during the product/system lifecycle including deliverables created by other functions/organizations to assure product and process compliance.
Maintains a working knowledge of generic products/services and Quality Engineering techniques, addresses problems of diverse scope, requiring the evaluation of identifiable factors, demonstrating sound judgment in selecting methods for obtaining solutions, and frequently interacts with supervisors and functional peer groups to gain cooperation of others.
Acts as an advisor to subordinate(s) and cross-functional partners, providing guidance to meet schedules and/or resolve technical problems effectively, develops schedules and performance requirements, and may have budget responsibilities.
Establishes and improves Quality & Regulatory (Q&R) capabilities supporting customer services business and leads in design and deployment of customer service strategy and solutions which exceed customer expectations.
Independently produces CAPA records and performs timely Corrective and Preventive Action (CAPA) engineering tasks, including assessment of issue descriptions and reviewing CAPA data sources.
You're the right fit if: (4 x bullets max)
1. Experience- 10+yrs of industry experience, must have experience in Healthcare/Medical device industry.
2. Skills- Validates key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs
3. Education- Bachelor's Degree/ Master's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.
4. Anything else-
Certifications: ASQ CQE or CQM preferred. 13485 auditor preferred
High-level English language proficiency including strong writing 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.
Indicate if this role is an office/field/onsite 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 commitment to diversity and inclusion here.