Quality Assurance / Regulatory Assurance Specialist
Design Quality Assurance (85%) :
- Participate in new product development projects by providing quality engineering services to assigned projects. Ensure defendable engineering and scientific analyses are employed and design history files comply with company policies and governmental regulations. Key deliverables including, but not limited to product performance analysis on similar products, risk analysis, failure mode and effects analysis, essential requirements checklist, design verification / validation, design transfer to manufacturing, documentation completion tracking, and product release authorization for distribution of product
- Review drawings to evaluate quality requirements including correct application of geometric dimensioning and tolerancing, proper use of engineering, process and material specifications, and identification of key characteristics for inspection plans and methods. Recommend revisions to assure design requirements are specified in the appropriate detail and clarity to provide a successful design transfer. Review and approve engineering change requests. Review product verification and validation plans and approve reports. Design Controls/Quality System
Regulatory assurance (15%)
- Coordinates and prepares document packages for regulatory submissions for Product Development Europe activities
- Supports project needs for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
- Compiles all materials required in submissions, license renewal and annual registrations.
Master or Bachelor degree
5 to 7 years of experience in the medical device industry, ISO 13485, MDD 93/42 and other regulations that may apply
Experience in the application of production and process controls including process validation, process control plans and statistical process control.
Experience representing their department during quality system audits
Experience in product mechanical evaluation & testing and GD&T
Fluent in English
Quickly available for a long term temporary assignment (min. 6 months)
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