Quality Engineer
Location:
Role:
- Industry: Engineering
- Job Type: Contract / Freelance
Application Details:
- Date Posted:
Quality Engineer
Job Title: Quality Engineer - Medical Device (Drug Development)
Location: Sweden
Contract: 12 Months
Job Description:
A 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 this role interests you, submit your CV below.
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