Quality System BPE
Part of the End 2 End program, the Quality System Business Process Expert supports the development, deployment and maintenance of the Quality Management System within Philips Healthcare, ensuring Philips cross sector harmonization, standardization and regulatory compliance.
You will ensure process compliance to regulations, and that optimization and efficiency are built into the Business Management and Quality Management System processes across all sectors and groups in partnership with the other business functions.
Location: Eindhoven, Netherlands with potential travel to Amsterdam, Netherlands
- Provide Computer system Validation support to the E2E Program teams to ensure consistent compliance with optimization and efficiency in E2E processes.
- Validation Business Process Expert, acting in support of the Philips Healthcare Quality Assurance team and Q&R Business Process Owner, across the Philips Q&R network for the E2E program.
- Provide guidance, review and approval of validation deliverables including but not limited to tool Classification, Risk analysis, Part 11 assessment, Validation Plan, User Requirements Specification, Validation Summary Report, etc.
- Report on status to E2E Q&R and Project management.
- Ensure that software applications and related infrastructures are validated for their intended use by a controlled and documented process in compliance with PMS, prior to issuance.
- Participate directly as the Philips Healthcare Quality Management System Business Process Expert in the validation of applications, in Philips Integrated Landscape. Ensuring compliance, efficiency and effectiveness of the processes within the Philips Healthcare sector, cross sectors, and at Philips corporate.
- Support cross-Philips setup and deployment of the Quality Management Systems along business model lines as identified by End-to-End teams.
Quality Assurance is an integral aspect of the global healthcare business including device design, development, manufacture, distribution, worldwide device marketing, sales, service, and post-market surveillance. This position is intimately involved in the process of ensuring Quality System Regulations are embedded within business processes and supports the harmonization of identified key processes by which the company and its sectors operate.
We are looking for
- Bachelor’s degree or equivalent preferably in a technical or engineering or/and IT related field(s).
- Minimum of 3-5 years of experience working in Quality Assurance / Quality Engineering / Quality Systems supporting multiple functional disciplines within a global medical (device/Pharma) industry.
- A comprehensive understanding of the diverse worldwide medical device quality regulations, including areas of device design, development, manufacture, distribution, worldwide device marketing, sales, service, and post-market surveillance.
- This position requires an extensive knowledge of FDA QSR’s, ISO 13485, JPAL, China GMP’s and other worldwide Quality System Regulations.
- An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization
- Skill set required for the department to operate:
- Thorough understanding of 21 CFR Part 11 & 21 CFR Part 820 and ability to translate this to IT requirements
- Thorough understanding of GAMP 5, V-model methodology and guidance documents: GPSV / AAMI TIR36.
- Thorough understanding of ISO 13485, ISO 14971, ISO 9001 and ability to translate this to IT requirements
- Hands on experience with end to end lifecycle of software validation ( Development , Operations/ Maintenance, Upgrade , Retirement)
- Good Understanding of SDLC, Agile and other development and project management methodologies
- Comfortable with working across time zones and seniority levels. Will need to be confident to provide guidance to teams.
- Project management experience, desired
- Good communication skills written & verbal in English
- Software validation experience: understanding of high-level view of the requirements and supporting processes.
- Demonstrated experience in collaborative working environments
- Experience addressing conflicts, escalation at team level to achieve desired results.
- Demonstrated experience handling deadlines, able to focus on targets
- Demonstrated experience-driving progress, taking initiative to achieve results.
- Experience understanding the process approach ‘End-to-End’, where, the optimization of customer value chain starts from ‘customer insight’ all the way to delivering products & service to the customers.
• Knowledge of 21 CFR Part 210 , 211
• Experience in working directly with FDA/MHRA/ TGA/ ANVISA/other regulatory inspections
• Auditing experience, either in supporting or doing audits
• Awareness of Lean methodologies
What we are NOT looking for, are candidates with
• Only theoretical knowledge of regulations / guidelines
• Only task execution experience
• Only testing experience (Unit Testing, Module Testing, Integration Testing, System Testing , UAT , Black box testing etc.)
• Only regulatory affairs experience (such as PMA, 510(k) and other FDA submissions)