Job title: Product Assurance Analyst (scientific/quality)
Location: Carlsbad, CA
Duration: 6+ months (Possibility of extension)
working hours: 8am-4pm
JOB ROLE:
路 The ideal worker needs to be able to process complaints and file Medical Device Reports.
Essential Duties And Responsibilities:
路 This individual will review, evaluate, and investigate product complaints relative to the identity, quality, reliability, safety, and effectiveness of Client products.
路 The Analyst will provide technical expertise and assistance in handling/categorizing complaints to comply with current FDA and international reporting regulations.
路 Duties also include compliance tracking, trend analysis and reporting to Management.
路 This individual must have excellent customer service skills, an analytical mind and the ability to evaluate and disseminate information from a global perspective.
Job Qualifications:
路 Evaluates incoming complaint information and maintains it in the electronic database.
路 Determines reportability (MDR/AE) of complaints to FDA and other international regulatory agencies.
路 Works closely with customers and sales representatives to respond to complaint reports.
路 Closely monitors quality, completeness and timeliness of complaint investigations and files.
路 Reviews, tracks, trends, analyzes and reports on complaint data to Management and other departments as needed.
路 Works with cross functional teams to ensure proper communication and evaluation/investigation of customer issues.
路 Participates in team decision making and displays team problem solving/communication skills.
路 Prepares and presents information in meetings and to upper Management
路 May serve a team member on projects/programs.
路 May provide guidance and training to support staff and new analysts.
路 May visit customer sites to meet with staff to discuss complaint issues.
路 May take lead on specific complaint issues and coordinate with other departments to further investigate.
路 May create/ or be responsible for revision of procedures/processes
路 Ad hoc reporting.
路 Complies with all health, safety and environmental policies.
Preferred Skills/Qualifications:
路 Regulatory and Quality Management skills Skills/Competencies: Customer service, Data analysis; Basic understandings of industry practices and standards;
路 Other Skills: MS Office, Written and verbal communication;
Education:
路 BS in clinical/medical, Engineering or science
Organizational Relationships/Scope:
路 Reports to Senior Analyst/Supervisor/Manager position as applicable.
路 Works closely with other local QA, International RA/QA, Sales, Marketing, Customer Service, R&D, Manufacturing, Engineering, Clinicals and Legal departments.
Working Environment/Physical Activities:
路 Usual 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.
路 Oral and auditory capacity enabling interpersonal communication as well as communication through automated devices such as the telephone.
路 Light physical effort required by handling objects up to 20 pounds occasionally* and/or up to 10 pounds frequently.
路 *Occasional: Activity exists less than 1/3 of the time. *Frequent: Activity exists between 1/3 and 2/3 of the time.
We do have referral bonus of $500 per candidate, if you refer any of your friends or colleague who are looking out for the same job.
Integrated Resources INC
https://careers.smartrecruiters.com/IntegratedResourcesINC