Address
Form of work
SalaryJob title:
Design Quality Manager
Your role:
- -Independently Produces and Completes Quality Engineering documents.
-Responsible for performing timely, detailed quality engineering tasks like: Assessing quality plans, assessing product designs and reviewing test and other performance data, analyzing market feedback, leading root cause
analysis and quality problem-solving.
-May also provide other quality engineering support, including assisting organizational units in leading the resolution of Quality engineering deficiencies.
-Works on issues where analysis of situation or data requires a review of relevant factors.
-Validates key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs. This is in close collaboration with the main
stakeholders like “R&D” engineers, PMS investigators, Risk Managers, Regulatory Affairs specialists, Product Industrialization Engineers, Reliability Engineers, etc.
-Provides effective oversight of the execution of the quality, reliability, PMS Plans, and Risk Management activities, and all of design related activities during the product/system lifecycle
-Supports stakeholders during the execution of quality system- and product audits and inspections.
-Within NPI and Sustaining Projects supports all ongoing Project activities e.g. coordinates Quality Norm planning activities, reviews and approves design deliverables, and guides the Project Team regarding open
Process/Quality questions.
-Identifies the problem and some relevant issues in deviating situations, analyses each, using standard procedures, and co-decides.
-Oversight of product reliability and design activities
-Manage the implementation and execution of a Product hold from start to finish.
-Ensure record completeness and compliance.
-Schedule the Market Hold Initiation Review Board meeting if it has been determined that a Hold will be extended to the markets
You're the right fit if: (4 x bullets max)
1. Experience =>10 years of experience in Medical device or regulated device industry
2. Skills: Basic understanding of global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485. ISO 14971 and IEC 60601 standards, Familiarity with factory SAP system, Understanding of product structures in SAP
3. Education: Bachelor’s engineering degree or equivalent experience.
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 commitment to diversity and inclusion here.
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