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Artech is currently seeking to add to the below position
Job Title: QA Complaint Investigator ( CAPA)
Job ID: TMO-REQ-006496
Location: 1 DNA Way, South San Francisco, CA 94080
Duration: 06 Months contract
Responsible for the customer complaint handling process, including logging complaints and performing and writing investigations.
Responsible for the initial QA review of a customer complaint and requesting initial follow up information/facts from Customer/Technical Services or the Distributor as required.
Responsible for monitoring the progress of complaint handling and investigation, and working with applicable individuals and departments to ensure complaint handling time requirements are met.
Responsible for tracking and trending complaints and preparing complaint analysis reports, highlighting any adverse trends.
Responsible for highlighting any potential reportable events to QA/RA Management as soon as possible as per the Medical Device Reporting/Vigilance procedures.
Responsible for the CAPA process, ensuring policies, procedures and practices are in compliance with global quality & regulatory requirements and meet the needs of our customers & Quality Policy.
Responsible for coordinating and capturing records of the Material Review Board, Quality Review Board, CAPA Review Board and other such reviews pertaining to the CAPA system.
Responsible for establishing and maintaining training materials for effective nonconformance handling, root cause analysis, CAPA handling; complaint handling and delivering such training to users of the applicable process.
Responsible for monitoring the progress of nonconformance investigation and each stage of the CAPA process e.g. CAPA determination & approval, CAPA implementation and CAPA effectiveness checks; capturing and reporting metrics and highlighting to management when CAPA processing target times are not being met.
Responsible for preparing & presenting data/reports regarding CAPA metrics (e.g. cycle times, number open, % effectiveness) for submission to Site, Divisional and Corporate Management Review.
Responsible for planning & performing nonconformance investigations when required.
Responsible for planning & performing effectiveness checks on CAPA when required.
Responsible for contributing to the continual quality & reliability improvement of APD products and services.
Ensuring policies, procedures and practices are in compliance with global quality & regulatory requirements and meet the needs of our customers & Quality Policy.
Responsible for performing tasks to support the quality system and quality policy as directed by QA/RA management.
Associates Degree required, with Bachelor's Degree a strong preference
Minimum 2 years of experience working within a QA/RA department.
Experience of working with FDA regulated products (Medical Device/IVD preferred) (pharmaceutical or dietary supplement experience is acceptable).
Knowledge of ISO13485 / FDA QSR Part 820 / 803 requirements preferred,
Experience working with complaint handling and/or CAPA & management review.
Knowledge of statistical data analysis tools and techniques.
Excellent interpersonal skills
Ability to work in a timeline driven environment
Excellent communication skills both written & oral
Excellent computer skills, particularly spreadsheets/graphical software tools (e.g. Excel)
Less than 5% travel (US, European & International)
Please apply on our company website (www.artechinfo.com) with reference to job ID, or contact me at Pradeep.V@artechinfo.com / 973.507.7539
Team Lead – Staffing
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.507.7539 | Fax: 973.998.2599
Email: Pradeep.V@artechinfo.com | Website: www.artechinfo.com
About Artech Information Systems LLC
Artech is an employer-of-choice for the last 25 years to over 7,500 consultants across the globe. We recruit top-notch talent for over 70 Fortune and Government clients coast-to-coast across the U.S., India, and China. We are #1 Largest Woman-Owned IT Staffing Firm in the US and this may be your opportunity to join us! For more check: www.artechinfo.com
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