Quality Compliance Specialist in Cordova, TN at Volt

Date Posted: 1/22/2020

Job Snapshot

  • Employee Type:
    Contingent
  • Location:
    Cordova, TN
  • Job Type:
  • Duration:
    48 weeks
  • Date Posted:
    1/22/2020
  • Job ID:
    214697
  • Pay Rate
    $27.07/Hour
  • Contact Name
    Volt Branch
  • Phone
    919/829-1660

Job Description

Volt is now hiring Quality Compliance Specialists to join our client’s talented team in the Memphis, TN area. This is an excellent opportunity to work with a dynamic leader in the medical device industry!

The duration of the assignment is up to 12 months.

The Quality Compliance Specialist is responsible for performing thorough investigations of product complaints in accordance with Company policy and external regulatory requirements, as applicable. The position also assists with Quality Management System reviews and quality audits.

RESPONSIBILITIES INCLUDE:

  • Facilitates the compliant handling process by receiving, reviewing and entering product complaint information into database.
  • Coordinates and prioritizes complaint investigations to ensure that complaints are processed in a timely manner.
  • Responds to client, regulators or others as necessary within time restrictions.
  • Organizes and facilitates meetings to discuss complaints, prepares meeting minutes, and follows up on action items.
  • Evaluates information obtained during complaint investigation to determine if device failed to meet specifications.
  • Evaluates complaint information and determines appropriate regulatory reporting requirements.
  • Prepare and submit reports to FDA and other regulatory agencies within required time frames.

QUALIFICATIONS:

  • Bachelor degree with a minimum of 1-year experience, or Associate degree plus 3 years’ experience in Regulatory, Quality Control, Healthcare or equivalent experience.
  • Knowledge of FDA regulations 21CFR Part 803 and ISO13485.
  • Knowledge of medical device products and manufacturing processes a plus. 
  • Knowledge of FDA, Canadian, European regulations and quality system regulations, helpful.
  • Ability to analyze data, looking for trends & finding ways to summarize and report findings.
  • Ability to prioritize work load to ensure accurate work within strict time frames in regards to investigating, answering & reporting   complaints.
  • Ability to multi-task and independently manage workload.
  • Must possess excellent verbal and written communication skills.  

Volt Workforce Solutions offers full-service staffing and talent management consulting to help local, regional, national, and international companies. Through niche recruiting expertise and project management, VWS delivers solutions in IT, Technology, Engineering, Accounting, Administrative, Call Center, Human Resources, Technical and Creative Communication, and Manufacturing.

Volt is an equal opportunity employer.