You can't change the direction of the wind, but you can adjust your sails to always reach your destination
Over de functie
Let us start with pin pointing some of the must have experience for this position:
- Medical Device Experience,
- Supplier Quality Experience.
You are responsible for
o Collaborating with R&D, Operations and Procurement personnel to proactively engineer quality and ensure compliance for raw materials, components, finished products etc., from suppliers.
o Developing and supporting regulatory compliance gaps at suppliers, including supplier quality system and process development activities.
o Managing the quality relationship with key suppliers.
o Owning and managing the systems, which directly measure, and control in- bound quality and compliance including Material/ Component Specification Standards, Supplied Material Risk Rating, Supplier Risk Rating, and Supplier Rating/Response.
o Ensuring quality conformity of supplies via active monitoring of the supplier performance and take corrective actions (incident, complaint handling), including supplier audits and follow up on system failures.
o Driving quality and compliance development and/or improvement at suppliers when needed; Philips face to supplier(s) on lean improvements.
o Ensuring compliance to regulatory requirements and procedures for regulated products/processes.
o Independently works to deploy common approaches and working methods to drive ‘’One Philips’’ towards Supply Base in the assigned BG or Market.
To succeed in this role, you should have the following skills and experience
o Bachelor degree in an engineering or science discipline, or equivalent.
o Current certification with a recognized accreditation body (i.e. RAB- QSA/ IRCA) or successful completion of ASQ certification as a certified Quality Engineer (CQE) and certified Quality Auditor (CQA) or Certified biomedical auditor or successful completion of a recognized Lead Auditor Course.
o 10 -14 years of total industry experience with 6+ years of related experience in a medical device or regulated industry.
o Applied knowledge of appropriate global medical device regulations, requirements and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO13485, ISO14971, European Medical Devices Regulation, Japanese MHLW Ordinance 169 and ISO9001.
o Experience with quality systems, quality tools and methodologies, including Critical to Quality, FMEA Root Cause Analysis , Pareto, 8-D, 5 Why, Statistical Methods for sampling, design of experiments.
o Experience in root cause analysis, corrective and preventive action methods.
o Expertise / experience in problem solving with quality tools such as 6-sigma/ 8-D/ CAPA/ FMEA/ 5WHY etc.
o Good Knowledge of production/ quality development and control methods; CtQ definition, DfSS, SPC, APQP, FMEA, Control plans, etc.
o Knowledge of labeling and packaging requirements.
o 5+ years of management experience.
The main location of this position will be HTC Eindhoven. However a big aspect of the role will be traveling to locations in the UK. One can think about a percentage between 50 and 60%.
You will be part of the Q&R team consisting of Quality Assurance Managers working for the businesses- Mother and Child Care & Pain Relief reporting to the Q&R Site Lead. 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.
Voor meer informatie neem je contact op met Bram Geerets via telefoonnummer 06-13888330
Werken voor Yacht
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