Quality Assurance Specialist, Complaint Handling
Posted yesterday
manpower san diegoSan Diego (CA)
SENIORITY
Senior
About the role
Summary:
Participate in product quality activities, for complaint investigations of company products. Facilitates cross functional discussions in identifying, documenting, analyzing and reporting quality issues and ensuring that customer feedback is appropriately evaluated. Facilitate functional area initiatives as needed. Provide colleagues support as needed.
Key Responsibilities:
Reviews individual cases, assess for potential adverse events for escalation to Regulatory in a timely manner Reviews individual for the evaluation of complaints, including assessment, investigation, containment, for determination of escalation Ensures adequacy of complaint records to GMP Standards (e.g. investigations, CAPA, NCs)Participates and conducts tasks associated with rotational “monitor” activities of Quality Assurance escalation mailbox Facilitates the evaluation of complaints, including assessment, investigation, containment, review, approval and determination of on-going needs Participates, facilitates, and/or supports complaint investigations and resulting CAPA activities Completes other activities as assigned Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Qualifications
Minimum Requirements:
Bachelor's Degree 2-5 years recent experience in Quality/Regulatory Affairs in a in vitro diagnostics device or medical device company
Before you apply
Applying takes about a minute. These four things decide how fast it moves after that.
Your profile is current
It's what we read first. Occupations, seniority and locations matter more than a long history.
Two examples you can talk through
Not a portfolio — just two pieces of work where you can explain the decisions and what you'd change.
A number in mind
What you're on now and what would make you move. We negotiate better when we know both.
Your notice period
Employers plan around it, and it's the question that stalls offers most often.
Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.
More like this