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 1996, IRI has
attracted, assembled and retained key employees who are experts in
their fields. This has helped us expand into new sectors and
Job Description Job title: Product Assurance Analyst
Location: Carlsbad, CA
Duration: 6+ months (Possibility of extension)
working hours: 8am-4pm
· 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.
· 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
· Prepares and presents information in meetings and to upper
· May serve a team member on projects/programs.
· May provide guidance and training to support staff and new
· May visit customer sites to meet with staff to discuss
· May take lead on specific complaint issues and coordinate with
other departments to further investigate.
· May create/ or be responsible for revision of
· Complies with all health, safety and environmental
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;
· BS in clinical/medical, Engineering or science
· Reports to Senior Analyst/Supervisor/Manager position as
· 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
Additional Information Thanks & Regards,
Integrated Resources, Inc.
DIRECT # - 732 – 318 -6506 | (W) # 732-549-2030 – Ext – 324 |