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Quality Compliance Specialist II in Cordova, TN at Volt

Date Posted: 4/16/2019

Job Snapshot

  • Employee Type:
    Contingent
  • Location:
    Cordova, TN
  • Job Type:
  • Duration:
    48 weeks
  • Date Posted:
    4/16/2019
  • Job ID:
    173326
  • Pay Rate
    $28.0 - $30.3/Hour
  • Contact Name
    Volt Branch
  • Phone
    919/829-1660

Job Description



Job Purpose

The Quality Compliance Specialist II 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, supports quality audits, and maintains departmental procedures that drive and ensure compliance with US and International requirements.



Essential Duties & Responsibilities

Complaint Handling

  • 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.
  • Resolves issues or provides clinical/technical explanation to complainant regarding reported event.
  • Ensures proper disposition of returned products for complaint analysis.

Regulatory Reporting

  • Evaluates complaint information and determines appropriate regulatory reporting requirements.
  • Prepare and submit reports to FDA and other regulatory agencies within required timeframes.

Post-Market Surveillance

  • Prepares and analyzes complaint reports on a bi-weekly, monthly and annual basis.
  • Participates in Post-Market Surveillance (PMS) activities.
  • Support corporate Regulatory Affairs by providing information for submissions and Annual Reports.
  • May perform other duties as assigned by supervisor

Training & Documentation

  • Create documentation and train departmental and corporate personnel on the complaint handling, adverse event/vigilance reporting requirements and monitor compliance.
  • Responsible for staying current on international regulations and incorporating any revision or changes needed into SOP’s, work instructions, etc.

Project Management

  • Monitor assigned projects and tasks to ensure compliance with regulatory agencies, protocols, agreements, and applicable corporate compliance requirements.  Responsibility may extend to oversight of other individuals/organizations.

Collaborating

Working cooperatively with others to help a team or work group achieve its goals.

Continuous Improvement

Originating action to improve existing conditions and processes; identifying improvement opportunities, generating ideas, and implementing solutions.

Managing Work

Effectively managing one’s time and resources to ensure that work is completed efficiently.

Technical/Professional Knowledge and Skills

Having achieved a satisfactory level of technical, functional, and/or professional skill or knowledge in position-related areas; keeping up with current developments and trends in areas of expertise; leveraging expert knowledge to accomplish results.

Working through vision and values

Keeping the organization's vision and values at the forefront of daily actions.

Education/Experience

  • Bachelor degree with a minimum of 2-year experience, or Associate degree plus 5 years’ experience in Regulatory, Quality Control, Healthcare or equivalent experience. 

Knowledge/Skills

  • 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.