€ 80,000 - € 90,000
Quality & Safety
Detachering via YER
Manufacturing, Medical & Health
Over deze vacature
In this role, you have the opportunity to:
Implement and manage quality engineering, purchasing controls and supplier quality processes related to the development, procurement and continuous improvement of manufacturing materials, components, software, sub-assemblies, contract manufactured finished devices/products or services, and their introduction into Philips supply chain.
You are responsible for:
- Collaborating with R&D, operations and procurement personnel to proactively engineer quality and ensure compliance for raw materials, components, finished products etc., from suppliers
- Developing and supporting regulatory compliance gaps at suppliers, including supplier quality system and process development activities
- Managing the quality relationship with key suppliers
- 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
- 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
- Driving quality and compliance development and/or improvement at suppliers when needed; Philips face to supplier(s) on lean improvements
- Ensuring compliance to regulatory requirements and procedures for regulated products/processes
- Independently works to deploy common approaches and working methods to drive ‘’One Philips’’ towards supply base in the assigned BG or market
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.
Location: HTC and travelling to UK (50% to 60% travelling).
We welcome you to a challenging, innovative environment with great opportunities for you to explore. YER is preferred supplier. You will be employed by YER and seconded to Philips.
Our benefits are very competitive and designed around your preferences:
- A competitive salary depending on experience
- Extensive set of tools to drive your career, such as a personal development budget, training and coaching
- Healthy work-life balance
To succeed in this role, you should have the following skills and experience:
- Bachelor degree in an engineering or science discipline, or equivalent
- 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
- 10 -14 years of total industry experience with 6+ years of related experience in a medical device or regulated industry
- 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 ISO900
- 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
- Experience in root cause analysis, corrective and preventive action methods
- Expertise / experience in problem solving with quality tools such as 6-sigma/ 8-D/ CAPA/ FMEA/ 5WHY etc.
- Good knowledge of production/ quality development and control methods; CtQ definition, DfSS, SPC, APQP, FMEA, control plans, etc.
- Knowledge of labeling and packaging requirements
- 5+ years of management experience