JOB TITLE : Quality Specialist - Post Market

TOP 3 SKILLS : 1) Previous complaint processing experience; 2) Previous QA - med device (2 years); 3) hardware / firmware experience preferred

LOCATION : Cypress, CA (Orange County)

DURATION : 6 months (likely to extend or convert)

RATE RANGE : $35-38 / hr

SUMMARY :

The Quality Specialist Post Market Temporary will provide hands-on support to ensure complaints are reviewed and assessed in a timely manner.

Duties include, but are not limited to, day-to-day complaint review, investigation reports, adverse event reporting, and complaints log and trend maintenance.

Our work environment is a fast-paced atmosphere, fostering excellent cross-functional collaboration. Most of all, we are passionate about delivering innovations that improve the quality of health care and the patient experience.

We are looking for like-minded individuals who are quality driven and patient focused to join our team!

RESPONSIBILITIES :

Evaluates complaints to determine complaint investigation, Medical Device and Vigilance Reporting in accordance with 21 CFR Part 803 Medical Device Reporting, European Vigilance Reporting.

Performs and / or coordinates complaint investigations and gathering of additional information, working closely with other departments to complete investigation reports

Evaluate all information from a technical perspective to ensure appropriate Analysis and Investigation

Reviews daily processes to ensure issues are being addressed and escalated in a timely manner

Maintains complaints log

Participates in process improvements

Perform other quality and regulatory-related duties as assigned

QUALIFICATIONS : Bachelor's Degree

Bachelor's Degree

Minimum of 2 years of experience in Quality Assurance with complaint processing role.

Previous experience in medical device with working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD / MDR

Must demonstrate the ability to investigate complaints with minimal guidance.

Strong problem-solving skills, critical-thinker, and experienced at investigating and resolving complex issues

Understand basic principles of good technical writing skills

Background with firmware / hardware related complaints investigation a plus

Attention to detail and timeliness are critical

Excellent communication (verbal and written) and interpersonal skills required

Basic knowledge of Quality Systems (CAPA / non-conformances / SCARS) a plus

Must be able to work under minimum supervision and in a team environment.

Must be a positive and energetic team player

IND123

Last updated : 2024-03-28