The Process Quality Engineer supports in achieving a state of high-quality performance and compliance in the factories while pursuing continuous quality improvement.
Your role:
- Analyzes defects for determining dispositions of non-conformances and drives management of Non-Conformances (NC) and Quality Notifications (QN) and implements effective Corrective and Preventive Actions (CAPA) actions.
- Helps to conduct the assessment of impact to Process Failure Mode and Effects Analysis (PFMEA) and associated controls in relation to design changes and assists in Manufacturing Process Development and Design Transfer activities.
- Supports operations performance monitoring, risk assessment, reporting, improvement and development, aids with improvement programs in factory, and supports analytical testing and Supplier Quality Engineering (SQE), Supplier Quality Assurance (SQA) and Purchasing.
- Coordinates timely quality engineering and quality assurance tasks, aids in ensuring manufacturing quality systems are maintained, and helps in completion of New Product Introduction (NPI) and product transfers in factory.
- Possesses working knowledge of generic products/services and Quality Engineering/Continuous Improvement techniques, exercises judgment within defined procedures and policies to determine appropriate action and frequently interacts with supervisors and functional peer groups to gain cooperation of others.
- Develops a multi-disciplinary approach and knowledge of basic principles relevant to quality engineering, theories and concepts, initiating process improvement activities.
- Identifies transformative process enhancement opportunities, facilitating the execution of advanced improvement initiatives to optimize operational performance and elevate product quality benchmarks significantly.
- Applies advanced statistical analysis techniques proficiently to interpret complex data trends and resolve medium to high complexity requests efficiently, exercising judgment within defined procedures/practices to determine appropriate action.
- Ensures the comprehensive execution of intricate process validation protocols, meticulously coordinating multifaceted production activities to bolster process validation efforts and drive continuous process improvements effectively.
- Prepares and delivers detailed quality metrics and reports to key stakeholders, highlighting significant achievements, emerging trends, and targeted areas for advanced improvement initiatives and regulatory compliance strategies.
- Participates in investigations and collaborates with suppliers, Research and Development (R&D), and manufacturing teams to resolve quality issues and maintain high standards throughout the supply chain.
You're the right fit if:
- You have a minimum of 2+ years’ experience in FDA regulated (ISO 13485) medical device quality /manufacturing environments, with a focus on quality operations, audit support, process validation/improvement, CAPA, non-conformance, PFMEA’s and Change management to manufacturing process/controls.
- You have strong experience/knowledge in the implementation of CAPA actions/ processes, non-conformances, including problem identification, root cause/defect analysis, implementation of solutions to prevent recurrence and drive continuous improvement.
- You’re experienced in supporting operations performance monitoring/reporting utilizing Quality insights/data analytics to lead continuous improvement throughout all stages of the product lifecycle.
- You’re able to build/cultivate relationships with supervisors, functional peer groups, internal/external stakeholders, suppliers etc.
- You have a minimum of a Bachelor’s Degree in Quality, Engineering or similar disciplines or equivalent experience in Quality Engineering.
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
Compensation:
Doing meaningful work should come with fair, transparent rewards. The base salary range for this role in Best, NL €48,000 - €81,000. We determine pay within the range using objective factors, like the skills the role requires, your relevant experience and the responsibility you'll have in this role, alongside internal equity and local market considerations.
How we work together:
We believe that we are better together than a part. 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 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 improve the lives of others.
- Learn more about our business.
- Discover our rich and exciting history.
- Learn more about our purpose.
- Learn more about our culture of impact with care.
Additional Information:
- May travel up to 10%
Skills Required
- Minimum 2 years of experience in an FDA-regulated, ISO 13485 medical device quality or manufacturing environment
- Experience with quality operations, audit support, process validation and improvement, CAPA, non-conformances, PFMEAs, and manufacturing process or control changes
- Strong knowledge and experience implementing CAPA processes, root-cause analysis, defect analysis, and recurrence prevention
- Experience monitoring and reporting operations performance using quality insights and data analytics
- Ability to build relationships with supervisors, functional peers, internal and external stakeholders, and suppliers
- Bachelor's degree in Quality, Engineering, or a similar discipline, or equivalent Quality Engineering experience
- Ability to perform the minimum physical, cognitive, and environmental job requirements with or without accommodation
Philips Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Philips and has not been reviewed or approved by Philips.
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Retirement Support — Retirement support is positioned as a standout, including a strong 401(k) match (often described at 7%) alongside pensions in some contexts.
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Flexible Benefits — Flexible benefits are emphasized through choice in health insurance options and a broad “Total Rewards” approach that combines compensation, health and wellness, and work-life support.
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Leave & Time Off Breadth — Leave and time off breadth appears strong, with generous paid time off and policies covering parental leave, caregiving responsibilities, volunteering, and family medical leave.
Philips Insights
What We Do
As a leading health technology company, it is our purpose to improve people’s health and well-being through meaningful innovation. Our goal is to improve 2.5 billion lives per year by 2030. We're always looking for ways to make life better – not only for our customers, but also for everyone working here. That's why we're taking steps to create an environment where we all acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success.
