21 days old

Senior Quality Assurance Scientist-Medical device experience

Kelly Services
Chaska, MN 55318
**Kelly Services** is currently seeking a **Senior Quality Assurance Scientist** in **Chaska, MN** to work a contract assignment 5 **month duration** for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100 companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.

**Primary Responsibilities includes:**

Job Description: The Chemistry and Immunoassay product portfolio is diverse and includes new concepts for hardware, software, and clinical decision applications. The Senior Quality Assurance Scientist contract associate will be involved in creation and/or updates of design history file documentation needed to support IVDR In vitro diagnostic regulations EU 2017/746 . This position will report to the Director of Quality Assurance and will be based in Chaska. The Senior Quality Assurance Scientist contract associate will assist in compiling documentation for IVDR submissions.

Responsibilities include: Create templates for reagent and/or system design history file documents, including population with applicable data and required content to conform to internal Quality System requirements and IVDR requirements. Collaborate effectively with other functional IVDR team members in gathering required information for completion of the IVDR files. Clearly and quickly communicate when potential gaps are found. Work with minimal direction to complete assigned project deliverables, procedural updates, assessments, or data analysis task individually or delegate to quality function specialists within the organization. Ensure that assigned tasks are compliant to applicable procedural requirements as well as to regulatory requirements. Review and update product safety risk assessments. Ensure that risk management activities are performed in accordance with company procedure and ISO 14971; Review and approve Design History file documents in preparation for IVDR submissions. Ensure the product Design History File DHF is auditable, traceable, complete, and supports regulatory product registration needs.

BASIC QUALIFICATIONS: BS in Biochemistry, Immunology or related technical field with minimum of 5+ years of experience or Masters degree in field with minimum of 3+ years of experience, or Doctoral degree with 0-2 years of experience. 1-2 years of experience within Medical Device product design and/or manufacturing environment. 1-2 years of experience on cross-functional team and/or managing projects involving multiple tasks. Demonstrated knowledge of design control processes, including design change, risk management, design requirements, design V V, and design transfer. Fluent in English language. Proficient in word processing, spreadsheets, MS PowerPoint, and project management skills. Well-developed written and oral skills.

DESIRED/PREFERRED QUALIFICATIONS SKILLS AND EXPERIENCES BEYOND BASIC QUALIFICATIONS : Well-developed skills in writing, review documentation, and oral communication within a technical team. Practical experience in other Quality disciplines Supplier, Manufacturing, Design, Post-market Surveillance, Quality Systems, and Quality Control . Knowledge and understanding of MDR/IVDR. Experience in product development and manufacturing processes in Diagnostics industry. Experience in a regulated industry specifically knowledgeable of IVD and Medical Device industry


**For immediate consideration, please send your resume in a WORD document to**

**Why Kelly** **** **?**

As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

**About Kelly** ****

At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.



Posted: 2020-10-09 Expires: 2020-11-09

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Senior Quality Assurance Scientist-Medical device experience

Kelly Services
Chaska, MN 55318

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