Process Quality Engineer

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

Benefits offered by this job

Travel up to 10%

Job summary

Philips Iberica SAU is seeking a Process Quality Engineer to support high-quality performance and compliance across our manufacturing sites, driving continuous quality improvements.

You will analyze defects, manage non-conformances, CAPA actions, and participate in PFMEA assessments, design changes, and NPI transfers, collaborating with suppliers, R&D, and production teams to elevate product quality.

Qualifications

• 2+ years in FDA/ISO 13485 medical device quality environments.
• Experience in CAPA, non-conformances, PFMEA and change control.
• Skilled in quality operations, audit support, process validation and improvement.

Responsibilities

• Analyze defects and manage Non-Conformances (NC) and Quality Notifications (QN).
• Implement corrective and preventive actions (CAPA).
• Support PFMEA assessments and assess impact of design changes.
• Coordinate quality metrics and reports for stakeholders.
• Collaborate with suppliers, R&D and manufacturing to resolve issues.

Skills

Quality operations

CAPA actions

Non-conformances

PFMEA

Data analytics

Statistical analysis

Quality reporting

Education

Bachelor’s degree in Quality/Engineering

Tools

QMS software

Statistical software

CAPA tracking system

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 to10%