Quality Engineer

2 weeks ago


Malmo, Skåne, Sweden g2 Recruitment Full time

Direct message the job poster from g2 Recruitment

Recruiter | Specialist in placing Mechanical and Composite Design Engineers in the EU Market

Job Title: Quality Engineer – Medical Device (Drug Development)

Location: Sweden

Contract: 12 Months

Job Description:

My client is seeking a Quality Engineer to ensure compliance with international quality standards in the development of medical devices for drug delivery systems. You will work closely with R&D, manufacturing, and regulatory teams to uphold quality and drive continuous improvement throughout the product development lifecycle.

Key Responsibilities:

  • Ensure compliance with FDA, ISO 13485, and other relevant standards.
  • Conduct risk assessments and support design control activities.
  • Maintain and review documentation for regulatory compliance.
  • Collaborate on process improvements and manage supplier quality.
  • Support audits and change management processes.

Qualifications:

  • Bachelor's degree in Engineering or a related field.
  • 3+ years of experience in quality engineering (medical device or pharma).
  • Knowledge of ISO 13485, FDA regulations, and risk management.
  • Strong communication and problem-solving skills.
  • Experience with drug/device combination products is a plus.

If interested in this role, please send your CV to sam.carson@g2recruitment.com or call +49 8954195904

Seniority level
  • Mid-Senior level
Employment type
  • Contract
Industries
  • Pharmaceutical Manufacturing and Medical Equipment Manufacturing
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