ExacTech, inc.

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Post Market Surveillance Specialist

at ExacTech, inc.

Posted: 6/12/2019
Job Status: Full Time
Job Reference #: a8b4465b-f3f1-45d4-b5bc-ec7c1c18a9a4
Categories: Other/General
Keywords:

Job Description

Duties and Responsibilities (Key Deliverables):

  1. Coordinate and track issues that are escalated for consideration for Filed Corrective Action, CAPA and other potential actions per Exactech procedures, including, but not limited to:
    • Plan, conduct, and document Correction and Removal Committee meetings
    • Track, communicate and follow up with team members to complete all action items in a timely manner
    • Track and drive committee to decisions in a timely manner
  2. Analyze post market surveillance data as requested by internal business partners.
  3. Providing training to employees, sales agents/representatives regarding the internal requirements for issue escalation.
  4. Assist the Sr. QA Manager, Post Market Surveillance with analysis and interpretation of complaint data for regulatory submissions, regulatory agency requests, monthly trending and/or management review.
  5. Prepares ad hoc report summaries as needed.
  6. Performs complaint trend analyses and product risk assessments as applicable.
  7. Communicates complaint data and relevant clinical information to internal customers in quality, risk management, manufacturing and new product development in support of complaint investigations.
  8. Represents the complaint team and provides support for cross functional teams, i.e. CAPA, Risk Management, Escalation, etc.
  9. Draft responses to Regulatory Agencies who inquire about complaint related issues.
  10. Knowing and applying Exactech’s Quality System and any appropriate federal and international standards.
  11. Assisting and supporting other employees, teams, and sales personnel as necessary.
  12. Practicing Exactech’s Values.

 

Job Requirements:

Education:

Associate's Degree from an accredited institution required; Bachelor's Degree preferred.

Experience:

  • Degree in Allied Health, Statistics, Epidemiology, Life Sciences or Biomedical Engineering, highly preferred.
  • Minimum of 2 years of experience working in Medical Device or Pharmaceutical FDA regulated environment. Experience in the areas of complaint handling, adverse event reporting, and/or correction/removal coordination, highly preferred
  • Working knowledge of requirements of FDA, MEDDEV (EU-MDR), and other global regulations related to complaint handling and Recalls/FSCA required
  • 1-2 years of experience in complaint handling, adverse event reporting, or correction/removal coordination is preferred
  • Experience with FDA/ISO quality management system regulations preferred
  • Experience in leading project teams preferred
  • Experience quality system management software, i.e. Pilgrim, TrackWise, CatsWeb, etc. highly preferred

 

Functional/Technical Knowledge, Skills and Abilities Required:

  • Above-average knowledge/skill in Excel, PowerPoint, Word, and Adobe.
  • Excellent analytical skills
  • Well-developed verbal and written communication skills.
  • Ability to effectively lead and present at meetings.
  • Detail oriented with strong organizational skills.
  • Self-directed, capable of setting own priorities and working independently to meet established deadlines