Quality Assurance Specialist

Please find below the job description : -

Title- Senior Quality Assurance Scientist

Location Chaska MN 55318 United States

Duration- 03 Months Contract+

Hours : 8 : 00am to 5 : 00pm

Payrate : $37 / hr. on w2 without benefits

Responsibilities :

The Senior Quality Assurance Scientist initiates, designs, develops and implements product design improvements and changes where analysis of situations or data requires a review of identifiable factors.

• The incumbent organizes and monitors field evaluations of current and new products for customer acceptance and validation;
• develops, recommends and reviews system design evaluations, service / maintenance plans and procedures, operator manuals and reliability requirements;
• directly assists customers on product performance issues; teams with Engineering and other departments to troubleshoot instrument and chemistry problems;
• assists with product definition and specification development; develops and executes test protocols to assess feasibility of product modifications;

and prepares service documents. The Senior Quality Assurance Scientist represents QA on current business or product improvement projects.

Assure accuracy of product labeling and compliance. Generate, prepare and issue complex data for assigned quality reports.

Responsibilities include complaint management activities and failure investigation quality oversight.BS, BA in a Life Science or related studies with 5+years in IVD industry or experienced with medical devices.

Knowledge of ISO / FDA requirements experience preferred.

Additional Job Details : The Quality Assurance Scientist- Senior for Client Diagnostics is responsible for Reagent Manufacturing Quality Assurance.

This position is part of the Reagent Quality team located in Chaska and will be an on-site position .

Our vision is to advance healthcare for every person. You will be working on the Reagent Quality team led by the Quality Assurance Manager responsible for Reagent Manufacturing Quality.

If you thrive in a role that prioritizes teamwork and collaboration and want to work to build world-class medical devices read on.

In this role, you will have the opportunity to :

• Provide Quality Assurance support for Reagent manufacturing of medical devices.
• Ensure compliance to design change procedures, corporate policies, and global regulations (FDA QSR, ISO, etc.) and make decisions / provide guidance to prevent a deviation or non-conformance
• Work with cross-functional team to identify, contain and disposition non-conforming product
• Effective interaction with development, technical operations, and manufacturing staff to ensure quality, strive to minimize the costs of reworking or waste and maximize customer satisfaction with the products
• Establish and drive to daily management actions for quality processes that support corporate initiatives
• Evaluate quality system performance and lead kaizen events to improve process efficiency.

Education :

• The essential requirements of the job include : BS, BA in a Life Science or related studies with 5+years in IVD industry or experienced with medical devices.
• Experience working in a regulated industry It would be a plus if you also possess previous experience in :
• Experience working in Quality Assurance
• Experience with medical device industry.
1 day ago