Vacancy Quality Manufacturing Manager – Utrecht


Organization

1 JUN ’22: For a rapidly growing Medical Devices scale-up, we are looking for a Quality Manufacturing Manager. The organisation develops and produces innovative and life-changing electronic Medical Devices to give people more time to enjoy life. This organisation is one that people can rely on. The organisation is experiencing tremendous growth and is expected to become a global leader in the near future. Around a 100 talented and ambitious professionals who believe in a work hard/play hard approach work at the organisation.

Function

As the Quality Manufacturing Manager, you oversee all Quality-related activities related to production. The main tasks exist of leading a team of Quality professionals and implementing strategies. This includes setting up Quality control methodologies, principles, systems,, and improvement projects, and Supplier control. For guaranteeing compliance with all regulatory, legal, and Company policies and procedures you will train employees, Compose, audit, and support the Quality Management System and other (Quality) documentation, and analyze/report operational metrics.

  • Oversee Manufacturing Quality exercises, including however not restricted to:
  • Leading the Quality Manufacturing Team
  • Non-conformances management
  • Overseeing of corrective and preventive actions
  • Inner and outer manufacturing quality audits
  • Risk analysis – analysis of data
  • Management responsibility and quality records
  • Give (quality) training where considered significant
  • Compose, audit, and support Quality Management System and other (Quality) documentation
  • Hands-on management role that actively contributes to the activities above while developing the Manufacturing Quality team – working to monitor and ensure adherence to company quality standards, regulatory requirements, and the QMS
  • Oversee inspection and release of raw materials, parts, semi-final products,, and final products, pre and/or post sterilization
  • Decide the disposition of any materials/goods non-compliant with the specification
  • Set up Manufacturing Quality measurements and objectives
  • Work with all groups to assure the achievement of goals
  • Comprehend key business processes and ensure the team is focused on initiatives that help improve operational efficiency and overall compliance effectiveness at the same time
  • Screen evolving regulations, standards, and governmental activities interpret relevant information, take appropriate action to inform and educate stakeholders, and revise processes as necessary
  • Give direction and recommendations for adherence to quality standards
  • Prepare and participate in quality audits (internal and external)
  • Work together, develop, revise, review and communicate quality policies, procedures, and strategies
  • Achieve objectives by accepting ownership; Ensure work is undertaken within defined timescales
  • All work to be attempted and finished with a significant degree of precision and attention to detail
  • Working independently with minimal supervision as well as the ability to work closely with the teams from different departments

Requirements

A large dose of proactivity and hands-on approach is a must for this role. In addition:

  • Bachelors degree a technical, life science or related discipline
  • A far reaching comprehension of overall Medical Device quality guideline (ISO 13485, EEC 93/42, MDR and 21 CFR 820), Good Manufacturing Practices (GMP) and applicable Quality System Standards
  • Experience People Management
  • Demonstrated capacity to work independently, prioritise multiple projects, address multiple issues in a hands-on, timeline driven environment
  • Talented in driving and tutoring staff through influence rather than position power to achieve significant results
  • Experienced in applying solid expert morals and good instinct to take decisive action
  • Fluency in English and Dutch

Pre

  • Master’s degree in a technical/scientific field or an additional business degree/equivalent experience
  • Start-up/Scale-up experience

Offer

Besides working for a rapidly growing organisation, the company offers you:

  • 25 holidays and up to 13 ADV (time for time) days per year
  • Defined benefit pension scheme and disability insurance
  • 40 hours per week to be worked anytime between 07:00 to 19:00
  • Assistance for the 30% tax ruling
  • Social events
  • Great and relaxing atmosphere in the office
  • Informal dress code

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Quintes Hamer

Senior Associate Quality & Regulatory | Medical Devices

+31 6 82 10 07 58
+31 23 754 86 60
q.hamer@qtcrecruitment.com