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Senior Post Market Surveillance Analyst in Fremont, CA at Stryker Corporation

Date Posted: 2/7/2019

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 Senior Post Market Surveillance Analyst, you will participate in the result of product design. You will assess our customer feedback and analyze impact to our regulatory agencies. You will decide reportability and escalation if issues related to the design process. You will be expected to collaborate with cross functional teams, including; safety, marketing, product investigation teams and engineering.

  • You will gather, record and complete documentation related to all facts of the complaint.
  • You will document and write the story of what transpired ensuring there is a clear picture represented by the facts for the end user.
  • You will provide leadership in process improvements, approve clinical trial reporting requirements and manage data reporting requests.
  • You will be a cross functional communicator of data; you must be able to conduct a careful study of data and information in a methodical way.

What you need

  • Bachelor’s degree in a technical or scientific discipline
  • 3+ years’ experience
  • Experience with Medical Device Reporting
  • Experience with NC/CAPA
  • Experience with External Audits
  • Knowledge / certification on medical device regulations and guidelines
  • Detail oriented approach to work
  • Time management skills and prioritization are key
  • Knowledge if risk management

Work From Home: Yes

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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