Philips Quality Engineer (m/f) in Boeblingen, Germany
As part of the Quality & Regulatory (Q&R) organization within Royal Philips, your challenge will be to guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve. As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of a COE, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the well-being and care for people around world.
Ensures that appropriate quality plans are made and a suitable quality system is in place, for both New Product Introductions (NPI’s) as well as for ongoing manufacturing that include all stages of the manufacture of the product/system and supports Quality System (QS) design.
Validate risk analyses and risk mitigation plans and activities, control plans, and Quality Systems.
Oversee processes: trend analysis, assess impact and follow-up (e.g., in QS updates, control plans, competency upgrades, etc.).
Review calibration plans and records, environmental controls, and training plans and records.
Organize IQA audits, and execute internal audits for regulated products to assess the effectiveness of the QMS linked to production controls.
Approve which processes need validation/re-validation after changes, and verify processes and plans/records.
Accountable for ensuring Manufacturing quality systems are established, maintained and documented according to needs of the business, customers and applicable quality system standards ®ulations.
Provide oversight of Q&R Manufacturing NPI projects ensuring timely completion of project deliverables, correcting issues delaying completion and reporting on quality system status of projects on manufacturing department or site level.
Support problem analysis and establishing corrective action (CAPA)
Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech division, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA). A person who is excited by new challenges, has strong technical competencies, and demonstrates resilience is most likely to succeed in these challenging, often demanding situations. However, by taking pride in all you do and inspiring others around you to prioritize Quality above all else, you’ll be contributing to a higher Quality of life for billions and helping Philips deliver innovation that matters.
We are looking for
Education in a Technical or Clinical discipline or equivalent professional qualification and experience
Demonstrated effectiveness in independently investigating problems and moving them towards resolution
Organized/structured work approach
Strong English and German communications skills, written and oral
High reliability and quality focus
High engagement, motivation and flexibility
5+ years industrial experience
Education/Experience in the quality, compliance or regulatory area, preferably in a healthcare environment
Experience in a regulated industry environment
Knowledge of quality tools/techniques and analysis methods
Experience in an international environment
Philips encourages people with a disability to apply.