(USA-PR-Guayama) QA Specialist

Bachelor’s Degree in Engineering, Biology, Chemistry or Medical Sciences, as minimum. ≥ 3 years of experience working in the pharmaceutical and/or medical devices industry. Proven experience in quality control / assurance on a relevant role. Good knowledge on quality standards as defined by USA-FDA 21CFR820 (Quality System Regulation), EN ISO 13485:2012 (Medical devices – Quality management systems – Requirements for regulatory purposes) and EN ISO 11135-1:2007 (Sterilization of health care products — Ethylene oxide. Thorough knowledge of general methodologies of quality assurance and standards (ISO and FDA). Excellent numerical skills and understanding of data analysis/statistical methods. Great attention to detail and a results driven approach. Excellent organizational and leadership abilities. Proven knowledge and experience on sterilization processes as applied to the pharmaceutical / medical devices industry. Certification of quality assurance / control is a strong advantage (ISO 9000, ISO 13485, etc.). About Kelly Services® As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $ 5.5 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter. Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.]] Category: Biotech/Clinical/R&D/Science
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