divh2Product Assurance Analyst/h2pIntegrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow./ph3Job Description/h3pJob title: Product Assurance Analyst (scientific/quality)/ppLocation: Carlsbad, CA/ppDuration: 6+ months (Possibility of extension) working hours: 8am-4pm/ppJob Role:/pulliThe ideal worker needs to be able to process complaints and file Medical Device Reports./li/ulpEssential Duties And Responsibilities :/pulliThis individual will review, evaluate, and investigate product complaints relative to the identity, quality, reliability, safety, and effectiveness of Client products./liliThe Analyst will provide technical expertise and assistance in handling/categorizing complaints to comply with current FDA and international reporting regulations./liliDuties also include compliance tracking, trend analysis and reporting to Management./liliThis individual must have excellent customer service skills, an analytical mind and the ability to evaluate and disseminate information from a global perspective./li/ulpJob Qualifications:/pulliEvaluates incoming complaint information and maintains it in the electronic database./liliDetermines reportability (MDR/AE) of complaints to FDA and other international regulatory agencies./liliWorks closely with customers and sales representatives to respond to complaint reports./liliClosely monitors quality, completeness and timeliness of complaint investigations and files./liliReviews, tracks, trends, analyzes and reports on complaint data to Management and other departments as needed./liliWorks with cross functional teams to ensure proper communication and evaluation/investigation of customer issues./liliParticipates in team decision making and displays team problem solving/communication skills./liliPrepares and presents information in meetings and to upper Management/liliMay serve a team member on projects/programs./liliMay provide guidance and training to support staff and new analysts./liliMay visit customer sites to meet with staff to discuss complaint issues./liliMay take lead on specific complaint issues and coordinate with other departments to further investigate./liliMay create/ or be responsible for revision of procedures/processes/liliAd hoc reporting./liliComplies with all health, safety and environmental policies./li/ulpPreferred Skills/Qualifications :/pulliRegulatory and Quality Management skills Skills/Competencies: Customer service, Data analysis; Basic understandings of industry practices and standards;/liliOther Skills: MS Office, Written and verbal communication;/liliEducation: BS in clinical/medical, Engineering or science/li/ulpOrganizational Relationships/Scope:/pulliReports to Senior Analyst/Supervisor/Manager position as applicable./liliWorks closely with other local QA, International RA/QA, Sales, Marketing, Customer Service, RD, Manufacturing, Engineering, Clinicals and Legal departments./li/ulpWorking Environment/Physical Activities:/pulliUsual Office environment with frequent* sitting, walking, standing, kneeling, crouching, crawling, balancing, stooping and occasional* climbing. Frequent* use of eye, hand and finger coordination enabling use of Office machinery./liliOral and auditory capacity enabling interpersonal communication as well as communication through automated devices such as the telephone./liliLight physical effort required by handling objects up to 20 pounds occasionally* and/or up to 10 pounds frequently./lili*Occasional: Activity exists less than 1/3 of the time. *Frequent: Activity exists between 1/3 and 2/3 of the time./li/ul/div
Product Assurance Analyst • Carlsbad, CA, United States
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