QA Officer

Bedrijfsnaam: -
Plaatsingsdatum: 23/10/2018
Standplaats: -


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 organisation, based in Noord-Brabant Netherlands.Role DescriptionTo provide Quality Assurance support and oversight to ensure compliance with Quality System and regulations that govern product development activities within the Interventional X-Ray (IXR) department

Responsibilities- Ensure compliance to all applicable regulations and internal procedures by proactively interpreting regulatory and quality requirements and determining way of working
- Support New Product Introduction by providing QA technical expertise, assessments, and strategies for problem resolution & prevention
- Serve as Subject Matter Expert for quality system and design control requirements within project teams
- Participate in risk assessments and take appropriate action during QA oversight activities to ensure adequate controls in relation to level of product quality, safety and business risks.
- Review and approve Product Design Quality Records (DHF documents such as specifications, risk assessment reports, validation & verification test protocols/results/reports, etc.)
- Review and approve Corrective Actions and Preventive Actions (CAPA) in order to meet compliance requirements.
- Review and approve product change controls for quality and regulatory compliance impact and determine requirements for implementation
- Accountable for interactions to enhance QA reputation within the company and to promote teamwork & understanding of quality requirements

Requirements- MS in related field plus 2+ years of QA experience, BS/BA in technical field with plus 4+ years’ experience.
- Demonstrated knowledge & expertise on subjects mentioned below but not limited to:
- ISO Standards (i.e., 13485, 14971, 14001)
- US, EU & International Medical Device Regulations (i.e., 21 CFR 820, MDD)
- Medical Device Design Control Requirements
- Lead / Internal Auditor Training
- Excellent Communication
- Excellent QA/Regulatory Writing Skills in English
- Proficient in Microsoft and other organizational tools
- Ability to effectively interact with various business departments & resolve QA compliance/technical issues/conflicts

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




Plaatsingsdatum :
Referentienummer :
Standplaats :
Adres :
Postcode :
9723 HK
Opleidingsniveau :
Uren :
Nader te bepalen
Dienstverband :
Werkervaring :
3 - 5 jaar
Contactgegevens :