Product Assurance Analyst

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.

Essential Duties And Responsibilities:

· 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

· Ad hoc reporting.

· 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.