Product Quality Assurance Engineer
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Job Description:
We are seeking a skilled Product Quality Assurance Engineer to join our team. In this role, you will be responsible for ensuring the quality and safety of our products from design to delivery.
Key Responsibilities:
* Representing quality interests on project teams
* Leading risk management activities and owning quality engineering tasks for new product development projects
* Reviewing design control compliance requirements and developing UFMEA & DFMEA
* Performing DOE's and statistical analysis to support product and process optimization
* Initiating corrective actions as required
* Supporting biocompatibility testing and participating in internal and supplier audits
Requirements:
* Third-level qualification in engineering, science, or a technical field
* Minimum of five years' experience in the medical device or pharmaceutical industry
* Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971, and CMDR
* Attention to detail, adaptability, problem-solving techniques, and excellent interpersonal skills
Why Join Us?
As a Product Quality Assurance Engineer at our company, you will have the opportunity to work on challenging projects, collaborate with talented professionals, and contribute to the development of innovative products that improve people's lives.