Kelly Services is looking for a Quality Engineer in Neenah, WI
Pay Rate: Negotiable
- The Specialist will support product development and lifecycle management in terms of pre-clinical safety and biocompatibility of medical devices, materials and processes.
- This role will work closely with project cross-functional teams to provide biocompatibility and other pre-clinical safety deliverables in compliance with ISO 10993 and other regulatory guidelines.
- The role requires knowledge of the medical device biocompatibility discipline throughout the product lifecycle and knowledge of biocompatibility regulations as they pertain to Class I and Class II devices.
- Candidate will work under the guidance of senior subject matter experts in biocompatibility and safety assessment, and must have strong ability to critically review scientific information and toxicology data.
1. Conduct biological safety assessment of medical devices and components, taking into consideration identified hazard, user or patient exposure according to intended product use or foreseeable misuse; develop technically sound biocompatibility safety assessment reports.
2. Lead the design, monitoring and interpretation of chemical characterization analyses, pre-clinical toxicology, biocompatibility and microbiological safety studies conducted under Good Laboratory Practices GLP , and when applicable, clinical studies conducted under Good Clinical Practices GCP .
3. Evaluate new product and changes in products per organizational risk management practices to ensure effective, safe and complaint devices are released to the market.
1. Bachelor of Science degree in toxicology, biomedical engineering, biological sciences or related field; an advance degree MS or PhD in these fields is highly preferred.
2. 5-7 years relevant industrial experience in the medical device field with expertise in biocompatibility and toxicology.
3. Fundamental understanding or direct experience with ISO 10993 standards, biomaterials, toxicological assessment, extractable and leachable analysis, medical device manufacturing processes, and biocompatibility assessment methodology.
4. Demonstrated proficiency in authoring biocompatibility risk assessments and the ability to independently design and implement effective testing strategies and protocols.
5. Must be team oriented and able to work well with diverse cross-functional teams and to interact in a professional manner with all organization levels.
6. Must possess strong analytical and process skills and be computer proficient.
7. Excellent technical writing
With Kelly, you'll have access to some of the world's highest-regarded scientific organizations— providing you with opportunities to work on today's most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you'll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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