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Quality Design Control Engineer


Requisition Number: n/a

Region: Europe
Country: Denmark
City: Struer

Responsibilities

Medicom Innovation Partner is looking for an experienced Quality Design Control Engineer who has a passionate interest for being a part of a project organization creating unique products for people who need medical treatment.

You’ll work in collaboration with our external customers and internal colleagues in project teams, where your role is to plan, coordinates and follow-up on quality and regulatory activities. Projects typically involve different technical disciplines like mechanicals, HW, SW and wireless connectivity, and span from concept development, design and development and design transfer into production. Our Quality Management System (QMS) is designed to support these activities to secure the appropriate level of quality for the specific development project, including preparation of technical and regulatory documentation needed to support product approval and registrations where needed.

Participation in internal and external audits and contribution to continued development and maintenance of our QMS is a part of the job. 


Qualifications - Education & Experience

  • Master or Bachelor degree in engineering, chemistry, pharmacy or similar qualifications. Experience with design control within the medical device industry, quality and design assurance and product approvals and registration including CE-marking and FDA 510(k) is preferable, but not a requirement.
  • You have a strong quality attitude and mindset with hands-on execution. From previous experiences you know how to secure the required level of quality in an project evironment with many stakeholders - even in the more intensive phases of the projects. You are a self-motivated teamplayer, proactive, open minded and listen to input from colleagues and enjoy team collaboration to achive goals.
    • You are analytical and theoretical well-grounded. You are well-structured and understand the importance of providing the appropriate quality of documentation.
    • You have excellent written and verbal communication skills and you are fluent in written and spoken English.

Qualifications - Skills & Competencies

We offer you:

  • A challenging position in an international innovative and successful company in growth
  • An opportunity to become part of a team of dedicated and highly qualified Quality Assurance colleagues based in Struer, Denmark
  • Cooperation in cross-functional project teams with great opportunities to influence the daily work
  • Well-structured training and personal development of your competencies including the area of Medical Device and regulated development process
  • Participation in quality competence projects and tasks
  • Exciting career possibilities within the constantly growing area of medical devices

TO APPLY:

We process applications continuously. Please submit your application and CV soonest possible to
job@medicomip.com
or
Medicom Innovation Partner
Gimsinglundvej 20
DK-7600 Struer
Att.: Birthe Damsgaard

*LI-POST



 

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