Quality Process Engineer Manufacturing

Quality Process Engineer Manufacturing

Your challenge

The Quality Process Engineer oversees the Quality Assurance 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.

The processes include the introduction/validation of new/changed manufacturing processes and their associated Q systems, the trend analysis and monitoring of manufacturing processes and their environment, the remediation to non-conformances, and the development and improvement of Q systems.

You are having the ability to switch very easily between your hard en soft skills from engineering till operator level. Your main task is to ensure the quality and performance level of our existing processes. With this, your self-esteem and self-respect should be relatively high.

Your responsibilities

• Responsible for performing timely quality engineering and quality assurance tasks.

• Accountable for ensuring Manufacturing quality systems are established, maintained and documented according to needs of the business, customers and applicable quality system standards rulations at manufacturing line level and as individual contributor.

• Provide oversight of Q&R supported Manufacturing NPI projects ensuring timely completion of project deliverables, correcting issues delaying completion and reporting on status of projects at project level.

• Developing professional expertise, applies company policies and procedures to resolve a variety of issues.

• Qualified expert who is developing beyond entry level knowledge of the quality assurance and quality engineering field.

• Has working knowledge of manufacturing systems products and services. Frequently interacts with supervisors and functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules.

• Works on issues where analysis of situation or data requires review of relevant factors.

• Exercises judgment within defined procedures and policies to determine appropriate action

Your team

We are the competence center within Philips Health Tech for industrial quality tools and quality systems. We drive the quality of our products and processes to satisfy our customers and end users through supporting Operations and developing/deploying quality competences.

We are looking for

• Bachelor’s engineering degree, or equivalent experience.

• Basic understanding of global medical device regulations, requirements, and standards, such as ISO13485, and ISO9001.

• Preference 3+ years of experience in a medical device or non-regulated industry.