QA Complaint Investigator & CAPA Specialist

Manpower San Diego; San Diego (CA); Vor Ort; USD 70.000 - 90.000; Vollzeit

Zusammenfassung

Manpower San Diego is seeking a Quality/Regulatory Affairs professional to support complaint investigations and product quality activities within a medical device setting. You will review cases, assess adverse events, and escalate appropriately to Regulatory as needed.

Responsibilities include cross-functional discussions, documenting analyses, CAPA activities, and maintaining GMP-compliant records. The role requires a Bachelor's degree and 2–5 years of related experience in an in vitro

Qualifikationen

• Bachelor's Degree.
• 2-5 years recent experience in Quality/Regulatory Affairs in a in vitro diagnostics device or medical device company.

Aufgaben

• 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.
• 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

Kenntnisse

Quality management

Regulatory affairs

CAPA

GMP

Ausbildung

Bachelor's Degree

Jobbeschreibung

Manpower San Diego is seeking a Quality/Regulatory Affairs professional to support complaint investigations and product quality activities within a medical device setting. You will review cases, assess adverse events, and escalate appropriately to Regulatory as needed.

Responsibilities include cross-functional discussions, documenting analyses, CAPA activities, and maintaining GMP-compliant records. The role requires a Bachelor's degree and 2–5 years of related experience in an in vitro