US-NJ-Mahwah: Quality Assurance Complaint Analyst

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 13-Nov-2009

Quality Assurance Complaint Analyst

Essential Duties & Responsibilities:

• Monitor complaints for product trends and notify management of events requiring immediate action. • Follow up with Sales Reps and hospitals to obtain applicable information pertaining to reported events. • Obtain product function information in collaboration with engineers to determine reportability.

• Mentor/lead less experienced analysts through the process of decision making. • Continuously maintain, enhance and apply knowledge of applicable related federal and foreign regulations pertaining to Medical Device Reporting through training, reading, etc.

Qualifications:

• 3-5 years experience in the medical device industry analyzing product field complaints and performing root cause/corrective action analysis OR analyzing product complaints for reportability to the FDA and other Competent Authorities • Applied knowledge of regulatory requirements: 21 CFR, ISO 9001, Quality System Regulation and Medical Device Directive • Demonstrated project management skills • Demonstrated verbal, written and interpersonal skills • Demonstrated ability to work in a team environment; i.e., work closely with engineers and other team members in understanding device functionality and surgical techniques in evaluating complaints for reportability purposes • Demonstrated problem solving and troubleshooting skills • Demonstrated ability to approach work with positivity and energy, work effectively on a team, and advocate for product excellence and quality • Demonstrated results orientation with ability to effectively multi-task, learn quickly, respond to the urgent needs of the team; demonstrated long-term track record of delivering expected results on/before the agreed upon deadline • Literate in relevant personal computer applications with applied knowledge of Microsoft Office software • Applied knowledge of 21 CFR Part 806 and Regulatory Reporting requirements

To apply for this position, please visit this Website.

Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com