Quality and Reliability Engineer Laboratory Informatics
In this role, you have the opportunity to
drive key quality processes in the field of Laboratory Informatics software (LABOSYS and the new platform Laboratory Informatics) to enable us to create world class software which is safe and efficient.
You monitor the way of working, provide staff and management with appropriate visibility into the quality and compliance of our Laboratory Informatics software and propose process improvements to optimize the quality of these software products.
You are responsible for
- Primary quality (software) support, including evaluation of change notifications, quality issues, and identification of improvement opportunities.
- Report, execute, and/or support process improvements.
- Support (assisting/coaching) colleagues: project leads; process owners; line managers.
- Organize and administrate the Management Reviews.
- Support the organization in implementing a QMS, in compliance with external regulations and standards as well as Philips frameworks (PEPF).
- Lead the team when going through Audits by preparation/alignment of the Audit agenda with Auditor and Auditees and managing the timely follow-up on Audit Results.
- Provide support during DEKRA and Philips L1 and L2 audits.
- Facilitate the CAPA and audit finding processes, ensuring compliance of our organization related to international and internal regulations and procedures.
- Work with market Procurement and Supplier Quality to assure appropriate Supplier Controls are in place for Laboratory Informatics suppliers.
- Support the handling of safety complaints including reporting to C.A.
- Advice regarding milestones and approve release for delivery for all releases.
- Identify opportunities for improvement in processes by: Verification of compliance; Determining performance indicators and measuring the performance together with the process owner.
- Review deliverables (on quality aspects but sometimes also on content) and propose and execute improvements.
- Develop, implement and monitor quality metrics. Communicate status and progress.
To succeed in this role, you should have the following skills and experience
- BSc/MSc degree education.
- At least 2 years+ experience in regulated industry.
- Knowledge and experience in Quality Management System maintenance and development.
- Experience or understanding of Corrective and Preventive Actions process, Root Cause Analysis tools, or proven experience in problem solving.
- Experience in medical device product development and knowledge of Medical device regulations is a strong benefit.
- Experience in/understanding of software development through Agile is a strong benefit.
Systematic, analytic and precise mindset. Passionate and positive attitude. Strive for high performance and quality.
Team and communication skills:
o Ability to successfully incorporate and manage stakeholder needs. Ability to build consensus at all levels including global interactions.
o Communicate globally, across teams and programs, from senior leaders to administrative support personnel.
o Good skills in spoken/written English.