JOB DESCRIPTION

Partial Job Description

1) Evaluate incoming information and the relationship between the product and any clinical event and communicate event investigation via regulatory reports within globally required timelines

2) Provide timely communication and follow-up on customer complaints to customers, sales representatives and international business coordinators

3) Process governed by FDA Quality System Regulations (QSR), ISO 13485:2003, MDR/MDV and other global regulatory requirements

4) Maintain accurate records and logs all complaint information from customers and company employees into the electronic complaint handling database

5) Record and report complaints to manufacturers of distributed products as stated in distribution agreements

6) Acknowledge receipt of complaint and generates closure letters, as appropriate

7) Conduct complaint reportability determinations (e.g., MDR, MDV and other global adverse event reporting regulatory)

8) Make reportability decisions and completes regulatory reports (e.g., MDR, MDV, etc.)

9) Conduct quality checks, peer or final approvals of complaint files prior to closure

10) Ensure timely complaint closures, meeting both internal and external requirements and goals, by tracking complaint status and samples from the customer thru to file closure

11) Complete complaint files closure activities

12) Monitor continuous complaints for potential trends

13) Ensure secure and accurate maintenance of the complaint database

14) Review medical records for event information to determine regulatory reportability or to respond to corporate legal inquires

15) Review medical images

16) Support service & repair (as applicable)

CRITICAL REQUIREMENTS

• Qualifications / Skills Required

  
  

  1) Bachelors degree in technical field

  
  

  2) Experience of 4 years in Quality Assurance in medical device manufacturing environment

  
  

  3) Experience in CAPA

  
  

  4) Strong understanding of FDA Quality System Regulations (QSR), ISO 13485:2003, MDR/MDV and other global regulatory requirements

  
  

  5) Proficient in handling detailed and confidential information/data

  
  

  6) Ability to interface with companys internal and external global customers (medical professionals, etc)

  
  

  7) Ability to analyze and prioritize information

  
  

  8) Ability to read, write and understand English

  
  

  9) Good organizational and problem solving skills

  
  

  10) Effective communication skills (written and verbal)

  
  

  11) Advanced computer skills including database management, spreadsheet, charting and word processing

COMPANY INFORMATION

Sterling-Hoffman is a retained executive search firm that specializes in representing life sciences and technology companies in matters of high impact talent acquisition. Our clients include market leaders and venture capital-backed startups in industries such as: medical device, biotechnology, pharmaceuticals, enterprise software, clinical research, and laboratory services. You may view more of our jobs here: http://www.sterlinglifesciences.com Your privacy is important to us: we will never share your resume without your permission. Please note that only qualified applicants will receive a response. We encourage you to apply for as many jobs as you believe you are a fit for, but strongly suggest that you include your salary information as job seekers who provide salary information are likely to be reviewed sooner. ===================== TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Biotechnology Recruiter, Pharmaceutical Recruiter, Medical Device Recruiter, Biotechnology Career, Clinical Research Job, Regulatory Affairs Job, R&D / Scientist Job, Product Manager Job, Medical Device Sales Job, Biotechnology Sales Job, Quality Assurance Job, Engineering Job, Laboratory Jobs, Microbiology Jobs, CEO Jobs, Marketing Jobs, Manufacturing Jobs, Oncology Jobs, Cardiology Jobs, Hematology Jobs, Medical Jobs

JOB INFORMATION