Quality Project Leader
To ensure the Quality and Safety of Innovative (Medical and Non-Medical) products in a Dynamic Environment.
Key challenges include risk management, Post –Market Surveillance and co-ordination of quality activities with Engineering, Procurement, Manufacturing, Supply Quality, Clinical, Service and Support teams during the lifecycle of a product portfolio.
Enable the business by supporting and leading projects to ensure Product quality levels and work compliant in a lean way.
• Act as a single point of contact (person assigned to project team) responsible to ensure that products in assigned portfolio meet quality and compliance standards for every milestone of product Lifecycle maintenance by coordinating other Q&R input and support.
• Lead quality related problem solving and root cause analysis related to design, manufacturing, distribution and suppliers to drive and initiate improvements in new/ current project based on learnings/ feedback from earlier projects/ market. (both Safety and Quality feedback)
• Creates and Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates actions when required
• Instruct, coach and facilitate project team’s w.r.t Quality Management System (Procedures/ Policies/ Guidelines/ tools/ training, etc.) ensuring compliance to quality system requirements, regulations and standards in the designated area of responsibility
• Instruct, coach and facilitate project teams on relevant product standards (21 CFR820/ISO 9001/ISO13485/IEC60335/IEC60601/, etc.)
• Ensure execution of Product Quality test plans during the lifecycle of the product covering all aspects. (Product verification, early market feedback, ongoing reliability testing, etc.).
• Ensure regular communication on Quality status, compliance status, field call rate throughout the project execution within the project team and stakeholders.
• Leads all product safety/compliance related activities to ensure that the regulations and policies are fully and timely available and interpreted, products comply with all regulatory requirements and Philips policies and incidents are handled according to corresponding product safety/compliance incident handling process including review and decision making on product safety/compliance related escalations
• Ensure Risk Management quality (quality of UFMEA, DFMEA, PFMEA/HB-SRA, etc.).
• Ensures timely execution and required communications and escalation.
You will be part of the Q&R team working for the businesses- Mother &Child Care at Site, reporting to the PMS Manager. You will be based in Eindhoven, The Netherlands. You will work in project teams with co-ordination with marketing teams, manufacturing teams at various sites, supplier teams, and other Q&R members across Philips.
We are looking for
• Bachelor degree with 5+ years of related experience or a Master degree with 3+ years of related experience.
• Qualification / Training in Six Sigma and Statistics and proven experience in Problem solving and root cause analysis tools. Highly experience in using tools and methodologies such as Design-FMEA, Process-FMEA; CTQ flow down; SPC, etc.
• Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001.
• Preferably, experience in a medical device industry.
• Proven ability to successfully incorporate and manage stakeholder needs throughout a project
• Communicate globally, across teams and programs, from senior executives to administrative support personnel. Experience leading remote teams.
• Composure, conflict management, timely decision making, listening skills, self-motivation, and perseverance are all requirements of this position.
• Able to thrive in a fast-paced, team-oriented, new product development environment.
• Detail oriented and able to see the big picture