Senior Quality Lead Quality Compliance
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Job Location:
Amsterdam - Netherlands
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Job Title
Senior Quality Lead - Quality ComplianceJob Description
Your role:
Acts as Subject Matter Expert (SME) for non-conformance and Drive non-conformance reduction and process validation maturity in close cooperation with the Quality leads in Integrated Supply Chain.
Implement and provide oversight of consistent global Quality and Regulatory requirements related to elements supporting the overall operations and process controls.
Ensures that appropriate standards and processes are in place for new product introduction as well as for ongoing manufacturing that include all stages of the manufacture of the product/system.
Oversees the Quality Assurance activities in the processes related to the manufacturing of materials components sub-assemblies and completed products and their supply chain including compliance to regulatory requirements and /or procedures for regulated products /businesses.
Have an impact on processes such as the introduction/validation of new/changed manufacturing processes and their associated Quality systems the trend analysis and monitoring of manufacturing processes and their environment the remediation to non-conformances and the development and improvement of Quality systems.
You serve as best practice/quality resource within your own discipline or as technical expert on functional or cross-functional teams/projects. You also act on a global scale across all Philips businesses and factories.
This flexible role offers you the opportunity to work with international teams while benefiting from an office-based working model (spend at least 3 days working from the office and up to 2 days from home). Travel between 20-30% globally is required for strategic and key initiatives as well as leadership activities.
Youre the right fit if:
Youve acquired 5 years of experience in quality engineering with a full understanding of manufacturing and operations resolving a wide range of issues in creative ways including the introduction of new concepts. You have a relentless focus on Product Quality and Patient Safety and demonstrated leadership skills and ability to influence change and challenge status quo in respect to opportunities for improvement.
Your skills include strong knowledge of principles theories and concepts relevant to Quality Engineering (CQE body of knowledge); working knowledge of appropriate global medical device regulations requirements and standards. Strong knowledge of Risk Management Acceptance activities Non-Conformance Production and Process Controls and Process Validation activities.
You have a bachelors degree or higher in Engineering or related field (Mathematics Statistics etc.) and are Lean Six Sigma Green or Black Belt (or Master Black Belt) certified.
You must be able to successfully perform the following minimum Physical Cognitive and Environmental job requirements with or without accommodation for this position.
Youre an excellent communicator with strong negotiation and relationship management skills with a strong ability to make data-driven decision and move teams through vague and complex situations to develop clearly defined programs. Must be willing and able to travel to US Europe India and China up to 25%.
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 companys facilities. Field roles are most effectively done outside of the companys main facilities generally at the customers or suppliers locations.
This is an office-based role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters and we wont 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 youre 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.
#LI-EU
Required Experience:
Senior IC
Key Skills
- Quality Assurance
- Six Sigma
- Design Controls
- FDA Regulations
- ISO 9001
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
About Company
Philips has been revolutionizing lighting for over 125 years. We pioneered the world changing development of electric light and LED, and are now leading the way in intelligent lighting systems. Our deep understanding of how lighting positively affects people, enables us to deliver inn ... View more
