Product Assurance Analyst, Carlsbad

Integrated 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 ****, 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.
Job Description
Job title:
Product Assurance Analyst (scientific/quality)
Location:
Carlsbad, CA
Duration:
6+ months (Possibility of extension)
working hours: 8am-4pm
JOB ROLE:
· The ideal worker needs to be able to process complaints and file Medical Device Reports.
· This individual will review, evaluate, and investigate product complaints relative to the identity, quality, reliability, safety, and effectiveness of Client products.
· The Analyst will provide technical expertise and assistance in handling/categorizing complaints to comply with current FDA and international reporting regulations.
· Duties also include compliance tracking, trend analysis and reporting to Management.
· 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:
· Evaluates incoming complaint information and maintains it in the electronic database.
· Determines reportability (MDR/AE) of complaints to FDA and other international regulatory agencies.
· Works closely with customers and sales representatives to respond to complaint reports.
· Closely monitors quality, completeness and timeliness of complaint investigations and files.
· Reviews, tracks, trends, analyzes and reports on complaint data to Management and other departments as needed.
· Works with cross functional teams to ensure proper communication and evaluation/investigation of customer issues.
· Participates in team decision making and displays team problem solving/communication skills.
· Prepares and presents information in meetings and to upper Management
· May serve a team member on projects/programs.
· May provide guidance and training to support staff and new analysts.
· May visit customer sites to meet with staff to discuss complaint issues.
· May take lead on specific complaint issues and coordinate with other departments to further investigate.
· May create/ or be responsible for revision of procedures/processes
· Complies with all health, safety and environmental policies.
Preferred Skills/Qualifications
:
· Regulatory and Quality Management skills Skills/Competencies: Customer service, Data analysis; Basic understandings of industry practices and standards;
· Other Skills: MS Office, Written and verbal communication;
Education:
· BS in clinical/medical, Engineering or science
Organizational Relationships/Scope:
· Reports to Senior Analyst/Supervisor/Manager position as applicable.
· 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:
· 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.
· Oral and auditory capacity enabling interpersonal communication as well as communication through automated devices such as the telephone.
· Light physical effort required by handling objects up to 20 pounds occasionally* and/or up to 10 pounds frequently.
· *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.
Additional Information
Thanks & Regards,
Seema Chawhan
Clinical Recruiter
Integrated Resources, Inc.
DIRECT # - *************** | (W) # – Ext – 324 | (F)
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