190379 - QA Specialist
Industry
PRO
Region
CA-S.Cali-Los Angeles/Orange Counties
City
Fremont
State
CA
Rate
Up to $28.00 DOE
Duration
6 months
Description
Chipton-Ross is seeking a QA Specialist for an opening in Fremont, CA.

SUMMARY:
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.

RESPONSIBILITIES:
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

REQUIREMENTS:
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.

EDUCATION:
Accredited Bachelors’ degree or relevant experience with an Associate’s degree in clinical/medical discipline, engineering or science.

WORK HOURS:
Full-Time
Shift: M-F, 8-5pm (flexible)

Remote: Must be local, can work partially from home after training. May need to work onsite 2 days a week at the most.

Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.

Contact
Silmese Graves
sgraves@chiptonross.com
CHIPTON-ROSS, INC.
11832 Fishing Point Drive, Suite 100
Newport News, VA 23606

Phone: (757) 595-0005 x261 or (877) 244-5418 x261

Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.

Employment will be contingent on candidate clearing pre-employment drug screen and background check.

Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.