Process Quality Engineer

Philips International; Best; On-site; EUR 48,000 - 81,000; Full time

Job summary

Philips is seeking a Process Quality Engineer to elevate manufacturing quality in Best, NL. You will analyze defects, manage Non-Conformances and Quality Notifications, and drive CAPA actions to prevent recurrence while supporting PFMEA assessments and design transfers.

The role emphasizes data-driven quality improvements, supplier collaboration, and regulatory compliance. Office-based in Best with on-site work required; occasional travel may occur.

Qualifications

• 2+ years’ experience in FDA regulated (ISO 13485) medical device quality/manufacturing environments.
• Strong experience in CAPA actions, non-conformances, root cause analysis and implementing solutions to prevent recurrence.
• Experience with quality analytics, risk assessment and reporting across product lifecycle.

Responsibilities

• Analyze defects to disposition non-conformances and manage NCs and QNs.
• Lead CAPA actions to prevent recurrence and drive continuous improvement.
• Assess PFMEA impact and controls related to design changes.
• Support operations performance monitoring, risk assessment, reporting, improvement and development, and QA programs.
• Coordinate quality engineering tasks and ensure manufacturing quality systems are maintained.

Skills

CAPA processes

PFMEA knowledge

Quality data analytics

Non-conformances

Audit support

Education

Bachelor's Degree in Quality/Engineering or similar

Job description

Job Title Process Quality Engineer Job Description

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% At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health. Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we 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. It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism. To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. Know Your Rights