Quality Officer

Doorsturen
 
  • Aanbod € 60,000 - € 70,000
  • Functiegroep Engineering
  • Dienstverband Fulltime
  • Vacaturenummer 8704200
  • Locatie Best
  • Contract Detachering via YER
  • Branche High Tech

Over deze vacature

To 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.

Functie

Your 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

Bedrijf

With a growing presence in cardiology, oncology, and women's health, Philips operates in the areas of Imaging Systems, Patient Care & Clinical Informatics, Home Healthcare and Customer Services. Philips combines its clinical expertise and human insights to create innovative solutions across the continuum of care, in partnership with clinicians and our customers, to provide better value and expand access to care for millions. Our teams are working hard every day to improve patient outcomes all the way from disease prevention and screening to diagnosis, treatment, therapy monitoring, and disease management. Irrespective of whether the care cycle takes the patient from doctor's office to hospital or hospital to home, or simply from one medical department to another, Philips Healthcare's unique medical solutions are designed to optimize the quality and flow of patient information and clinical decision making.

Aanbod

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

Profiel

  • 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
Doorsturen