Sr Post Market Specialist

Company: SeaSpine
Location: Carlsbad
Posted on: February 23, 2021

Job Description:

If you are a job seeker with a disability and require a reasonable accommodation to apply for one of our jobs, you will find the contact information to request the appropriate accommodation by visiting the following page: As a Sr. Post Market Specialist on our Quality Team, your key deliverables will be performing complex investigations, managing risks in design and manufacturing and driving best-in-class surgical outcomes via the Product Monitoring process. As a member of this dynamic team, you'll be integral to the--SeaSpine engine of innovation and growth. Essential Functions:

• Perform failure analysis and root cause investigations on returned products including review of Risk Management files and Device History Records
• Document complaint analysis reports in our complaint management system
• Ensure complaint investigations are completed within the required time-frame
• Evaluate historical complaint data to identify trends
• Prepare summary and trend reports for evaluation in Management and other reviews
• Participate in Quality Management Reviews as requested
• Coordinate and host regularly scheduled reviews of post market data
• Update Risk Management documentation with post market data
• Prepare Health Hazard Evaluations to analyze potential field product issues
• Coordinate recall activities if required
• Define process improvements opportunities and implement solutions to improve the efficiency of post market activities
• Establish and implement post market related procedures and processes
• Support internal and 3rd party audits with post-market related requests
• Collaborate with other supporting departments in the resolution of quality problems using established problem-solving methodologies determining root cause and driving corrective and preventive actions where required
• Other Quality Assurance duties as assigned Required Qualifications:
  • High school diploma or equivalent
  • 5 years' Post Market experience in the Medical Device Industry
  • Demonstrated organizational and communication skills
  • Strong attention to detail
  • Demonstrated knowledge of FDA regulations, ISO 13485, CMDR, Medical Device Directive Regulation (93/42EEC), and other National and International regulations and standards Preferred Qualifications:
    • Bachelor's Degree
    • ASQ Certification Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Keywords: SeaSpine, San Diego , Sr Post Market Specialist, Other , Carlsbad, California