Senior Medical Device Expert

3 days ago


Copenhagen, Copenhagen, Denmark Pharmalogic Full time

Pharmalogic ApS is a small, dedicated consultancy services provider within the life science industry. We offer professional expertise in various areas, acting as experienced specialists or temporary employees to ensure quality and meet deadlines.

Our mission is to support the industry in achieving life-saving goals by sharing knowledge from highly specialized employees and training new junior employees to become skilled consultants.

We have a vision to be the most attractive employer where fun, development, and work go hand in hand. As a consultancy services provider, we prioritize offering social activities that bond us together within the different sections and as a company.

The position is open to English-speaking professionals, but Danish speakers will be preferred. Our Ideal Candidate should contribute to the community, help develop the Medical Device section, and Pharmalogic as a company.

We are seeking an experienced Senior Engineer with deep experience in working under ISO 13485 to lead tasks related to the manufacturing of medical devices or activities under the Medical Device QMS, such as change requests, risk analysis/mitigation, quality assurance, SOP updates, and deviation handling.

Key Responsibilities:
  • Manage and oversee the production process
  • Lead team meetings and coordination
  • Conduct risk assessments and implement mitigation strategies

Requirements:

  • ISO 13485 certification
  • Proven track record in Medical Device Manufacturing
  • Excellent problem-solving and analytical skills
  • Strong leadership and communication skills


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