Our client, a pharmaceutical company, is looking for a Senior Medical Device QA Associate their San Jose and South San Francisco location. The ideal candidate will have strong communication and facilitation skills which will align successfully in the organization.

　　Job Title: Medical Devices QA Associate

　　Location: San Jose, CA and South San Francsico, CA

　　Duration: 12 months

　　Pay Range: $55 - $62/hr

　　Schedule: M-F days

　　Job responsiblities

　　Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.

　　Contribute to Quality Assurance activities by performing investigation review/approval and other duties as assigned.

　　Independently assess investigation activities to determine potential Quality and Operational impact.

　　Suggest improvements and conduct continuous improvement activities.

　　Document deviations and escalate issues as appropriate to the Quality Assurance Lead in a timely manner.

　　Maintain regulatory compliance in accordance with current Good Manufacturing Practices.

　　Provide Quality Review and oversight of site cGXP documentation related to the operation of Sanford Production Operations and site activities to ensure compliance with global regulatory agencies and Pfizer quality standards.

　　Make decisions that may involve complex quality and technical issues.

　　Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives.

　　Qualifications

　　Must-Have

　　Applicant must have eight years of relevant experience; OR an Associate's degree with six years of experience; OR a Bachelor’s degree with at least three years of experience; OR a Master’s degree with more than one year of experience.

　　Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards.

　　Experience with DHR review and issuance of Certificate of Conformance

　　Extensive experience with ISO 13485 / 21 CFR 820;Prefer candidates that are certified auditors for 13485

　　Quality Management System (QMS) experience (i.e., administration/ownership of NCRs, CAPAs, Deviations, Management Review metrics, eQMS systems),

　　Advanced computer skills in MS Office applications and good knowledge of enterprise systems, such as SAP, Quality Tracking System (Trackwise), LIMS. ​​​​

　　About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells

　　ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.

　　ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.