Quality Assurance Manager

Bedrijfsnaam: -
Plaatsingsdatum: 23/09/2018
Standplaats: -

Functieomschrijving

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Medical Devices organisation, based in Noord-Brabant Netherlands.The CompanyA leading health technology company focused on improving people's lives through Innovation, a systematic approach and a path to value is how they distinguish themselves. An organisation with an international character and a lot of opportunities to develop yourself and grow.

Role DescriptionTo 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.

Responsibilities• Instruct, coach and facilitate project team’s 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.

Requirements• 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

Other informationDevelopment Quality experience, where one
o has worked with R&D (product development)
o can drive the product quality
o Risk management
o Ensure the product/consumer safety aspects
o Well versed with ISO13485 / IEC60601 / ISO 14971

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ravi Ramnarain Singh.

 

Aanbod/arbeidsvoorwaarden
-

Samenvatting

Plaatsingsdatum :
23/09/2018
Referentienummer :
95531
Standplaats :
-
Adres :
-
Postcode :
9723 HK
Opleidingsniveau :
HBO
Uren :
Nader te bepalen
Dienstverband :
Detachering
Werkervaring :
5 - 10 jaar
Contactgegevens :
bekijk