Sr. Quality Engineer

  • Job category Quality & Safety
  • Employment Fulltime
  • Reference number VAC-10010792
  • Location Eindhoven
  • Contract type Secondment via YER
  • Industry Medical & Health

About this vacancy

Are you the experienced Senior Quality Engineer, who is excited to work in a high-tech environment, and work on therapies that can be life-changing for people with a spinal cord injury?

Job description

As Senior Quality Engineer you will ensure that a Quality Management System is implemented and maintained within the organization in accordance with ISO13485, QSR 21 CFR 820, and applicable regulations (MDR 2017/745). You will also ensure the Quality Management System is implemented on a risk-based approach. You will lead the document control process.

Responsibilities:

  • Maintains the Quality Manual and the Process Map
  • Ensures the Quality Management System is compliant with ISO13485, QSR 21 CFR 820 and applicable regulations
  • Supports implementation of new processes, and updates of procedures
  • Coordinates the trending of Process Key Performance Indicators
  • Manages, schedules, executes, and follows the internal audit process as appropriate
  • Manages the Document Control process as part of the Quality Management System
  • Updates adequately QMS documentation and QMS Software
  • Promotes continuous improvement within the organization
  • Raises employees 'awareness of customers' requirements, the quality objectives and the results obtained

Company

ONWARD (formerly GTX Medical) is a medical technology company developing and commercializing innovative therapies to enable functional recovery for people with spinal cord injuries. Driven by its mission to restore movement, independence, and health, ONWARD builds on more than a decade of fundamental science and preclinical research conducted at the world’s leading neuroscience laboratories. ONWARD’s ARC Therapy, delivered by proprietary implantable or external systems, is designed to deliver targeted, programmed stimulation of the spinal cord in order to restore movement and other functions in people with spinal cord injury and improve their quality of life. 

Offer description

You will be employed by YER and seconded to our client. We offer:

  • Good employee benefits
  • Excellent guidance from your consultant and YER's back office
  • Friendly atmosphere and open culture
  • Community/network with other technology professionals from a variety of multinationals
  • Events and master classes with interesting speakers and attractive companies

Candidate profile

  • You have a Bachelor or Master’s degree in life sciences or engineering
  • You have 5 to 10 years with relevant industry experience in medical devices, preferably class III or AIMD
  • You have experience with QMS changes to support a fast-growing organization in an international environment
  • You have strong knowledge in ISO 13485:2016 for a full certification scope, preferably with MDSAP experience required
  • You have experience with QMS SW settings and use required
  • You have experience as internal auditor is desired
  • You have a strong drive to be precise and thrive on consistency
  • You have the ability to manage complex projects, also cross-functional projects
  • You are a highly organized individual with strong planning and organizational skills
  • You are results oriented and hands-on individual who enjoys working in an international, cross-functional environment in a fast-paced and growing company
  • You demonstrate the following characteristics:
  • Daring: passionate, imaginative, committed, independent and innovative
  • Pragmatic: solutions-oriented, direct, results-driven, creative, and resourceful
  • Rigorous: professional, resilient, inquisitive, and collaborative
  • Empathetic: caring, honest, encouraging
  • Positive: energetic, enthusiastic with a can-do attitude
  • Excellent English language proficiency, proficiency in French and/or Dutch language is highly appreciated