Post Market Surveillance Analyst in Fremont, CA at Stryker Corporation

Date Posted: 7/20/2019

Job Snapshot

Job Description

Who we want

  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
  • Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

What you will do

As a Post Market Surveillance Analyst, you will enter customer complaints into the company-wide complaint system and follows methods to analyze the complaints for the Neurovascular business. Responsibilities may include but are not limited to:

  • Review and determine reportability of complaints to FDA and international regulatory authorities
  • Write, review, and file Medical Device Reports (MDRs) and international Vigilance Reports
  • Works closely with Sales Representatives and health care professionals to obtain additional information
  • Monitor quality, completeness and timeliness of complaint investigations
  • Write customer response letters
  • Contribute to achieving team performance metrics and goals
  • Represent Quality function as a member on team projects to complete assignments or delegate assignments
  • Collaborate with other Neurovascular teams, customers, and regulatory agency representatives, to develop product solutions
  • Review team progress with management

What you need

  • Bachelor’s degree in a technical or scientific discipline
  • 0-2+ years of work experience
  • Experience with FDA Medical Device Reporting desired
  • Knowledge/certification on medical device regulations and guidelines
  • Detail oriented approach to work
  • Time management skills and prioritization are key

Work From Home: No

Travel Percentage: Up to 25%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation 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.

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