Quality Assurance / Regulatory Assurance Specialist

  • Contract type Temporary Assignment - bis auf weiteres
  • Place
    TOLOCHENAZ
  • Reference 149926-60-3
  • Assignment start date ASAP
  • Sector Chemistry & Life Sciences
  • Publication date 18.11.2019

Manpower

Quality Assurance / Regulatory Assurance Specialist

Your assignment

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.

Your profile

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)

Interested?

Are you interested in this job? Please use our online form to apply. We look forward to receiving your application.

About Manpower
Manpower Switzerland offers its customers more than 55 years of experience in the recruitment, selection and placement of permanent and temporary staff, as well as in HR solutions. Its network of 50 branches active in all linguistic regions, 20,000 temporary staff, 1,500 permanent placements and over 5,000 clients – including small, medium and large companies – in all sectors of industry make Manpower one of Switzerland’s leading providers of workforce management solutions.
 
Our 3 promises
“We are passionate about what we do. This passion is a motivating and driving force, ensuring excellent placement opportunities for you.”
“We care about the people we work with. Including you. That’s why our collaborations are based on trust.”
“We take on our responsibilities. For you, that means security and exciting prospects.”
 
 

 

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