Quality Assurance Specialist, Fremont, CA
Pay Rate: $28/hr
Shift: M-F, 8-5pm
Contract Duration: 6 months
Can work partially from home after training. May need to work onsite 2 days a week at the most.
- Provide oversight and subject matter expertise in handling change orders, complaints, non-conformances, CAPAs, variances in accordance with site specific and corporate procedures as well as current US FDA and international regulations.
- Review, evaluate, and investigate product and process non-conformances relative to the identity, quality, safety, and effectiveness of medical products.
- Identify, generate and publish metrics and reports related to the change orders, complaints, non-conformances, CAPAs, variances issues.
- Follow-up internally and externally to assure compliant, complete, and accurate files for change orders, complaints, non-conformances, CAPAs, variances, and product performance information.
- Support change orders, complaints, non-conformances, CAPAs, variances in internal and external audits and inspections.
- Ensure records (e.g., completion of investigations, risk assessment, review and/ or creation of documentation) associated with change orders, complaints, non-conformances, CAPAs, variances are adequate, accurate, detailed and timely.
- Collaborate with appropriate Technical, Clinical, Field/Sales, Operations and R&D resources to ensure assigned tasks are completed on time.
- Provide guidance to personnel to complete tasks compliantly, correctly, and timely, where the incumbent is accountable for the task.
- Analyze and report data using spreadsheets, graphs, and databases.
- Elevate issues to management as appropriate.
- Drive continuous improvement of the Quality System.
- Perform other duties as required
- Bachelors' degree or relevant experience with an Associate's degree in clinical/medical discipline, engineering or science.
- 3-5 years related experience in a regulated environment; preferable with medical devices or pharma.
- Knowledge of applicable international regulations and standards (CFR, IVDR, QSR, ISO 13485, ISO 14791, etc.).
- Medical device experience preferred.
- Non-Conformance and CAPA investigation experience is a plus.
- Regulatory and Quality Management knowledge and skills.
- Must have excellent customer service skills, an analytical mind and the ability to evaluate and disseminate information from a global perspective.
- Must have demonstrated ability to think strategically and be able to prioritize multiple tasks.
- Self-motivated and is able to work with little guidance for routine tasks
- Demonstrated ability to manage multiple activities and tasks.
- Demonstrated use of quality tools methodologies and strong computer skills.
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/non-traditional 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.]] 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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