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Philips

Quality Assurance Manager

Posted Oct 23, 2020
Project ID: PHILJP00022261
Location
Eindhoven , Noord Brabant
Duration
4 months
(Dec 15, 2020 - Apr 30, 2021)
Hours/week
40 hrs/week
Payrate range
41 - 60 €/hr

Your challenge


To assure the Quality and Safety of Innovative (Medical and Non-Medical) products in a Dynamic Environment.


Key challenges include risk management, design quality assurance activities and co-ordination of quality activities with Engineering, procurement, manufacturing, clinical, service and support teams. Supports organization to work compliant in a lean way.



Your responsibilities


-   Instruct, coach and facilitate project teams w.r.t Innovation Site Eindhoven-Quality Management System (Procedures/ Policies/ Guidelines/ tools/ training, etc.).


-   Instruct, coach and facilitate project teams on relevant product standards (IEC60335/IEC60601/21 CFR820/ISO13485, etc.)


-   Drives and supports quality & regulatory compliance to assure products & services comply with the Quality Management System / Business Management System requirements


-   Create quality function deliverables as per Innovation Site Eindhoven ?Quality Management System in projects, in Life Cycle Management and in Post Market Surveillance.


-   Review Requirements Management process and outcome.


-   Reviews Product Verification and Validation.


-   Ensure Risk Management quality (quality of UFMEA, DFMEA, PFMEA/HB-SRA, etc.).


-   Ensure compliance to quality system requirements, regulations and standards in designated area of responsibility.


-   Ensures timely execution and required communications and escalation.



Your team


You will be part of the Q&R team consisting of approximately 30 team members working for the businesses- Mother &Child Care, Skin Care, Connected Health Devices & Pain Relief reporting to the QAM Group 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.



We are looking for


-   Bachelor degree with 5+ years of related experience or a Master degree with 3+ years of related experience.


-   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.


-   Both detail oriented and able to see big picture



Preference


Since it is a short assignment, the candidate will be preferred with the following experiences:


-   "Compliant Handling"


-   Trackwsie tool


-   Philips experience



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