Customer Quality Engineer in Redmond, WA at Stryker Corporation

Date Posted: 11/19/2019

Job Snapshot

Job Description

GENERAL DESCRIPTION:

Responsible for continuous product and process quality improvements. Conducts investigations into NCs and CAPAs stemming from the products in the field. Leads root cause activities and Identifies potential failure modes and risks, and resolves customer issues appropriately.  Knows and applies the fundamental concepts, practices, and procedures of the general Quality and Regulatory environment, Post-market in particular.  

Essential Functions:

  • Gather and analyze Post Market trending data (e.g. Q, service reports, complaints, MDR/MDV) to identify opportunities for quality improvements
  • Champion and take ownership of activities that lead to improvement in Physio-Control Quality metric (Q)
  • Lead and/or support NC and CAPA process and NC and CAPA investigations
  • Communicate with Customers, members of Field Service and Sales organizations to gather information necessary to carry out investigations.
  • Provide outstanding customer support with investigation updates to internal and external customers
  • Work with multifunctional teams (Ex: R&D, Operations, Manufacturing Engineering, Field Service, and Sales) to drive resolution for NCs and CAPAs
  • May support Engineering Change Orders (ECO) and Process Change Orders (PCO)
  • Support and communicate with complaint handling function to ensure trending information is accurate and up to date
  • Champion determination of “true” root cause by utilizing appropriate problem solving tools
  • Document accurately and thoroughly NC and CAPA investigations
  • Conduct/Update risk analyses and track all findings, along with development of Risk Management portfolio, as required.
  • Calculate Failure/Harm occurrence rankings based on field data as required
  • Lead risk documentation updates based on field data.
  • Provide post-market input and feedback on safety, durability, craftsmanship, and reliability design input specifications for Quality report, design reviews, risk analyses, and customer research.
  • Develop statistical rationale for testing, when required, to address post market issues.
  • Develop the rationale for validation sample size, duration, and number of locations.
  • Support quality assurance engineering responsibilities after launch with post market monitoring and voice of customer.
  • Contribute to maintaining the risk management portfolio for product life.
  • Provide Post Market trending data (e.g. Q, service reports, complaints, MDR/MDV) to the organization Present Post Market trending data to the business
  • Monitor compliance to Quality Procedures and FDA Quality System Regulations (QSR’s) and update as necessary.
  • Support field action related activities i.e. investigations, HHEs, presentations etc.
  • Support internal and external audits (FDA, ISO, MDSAP etc.)

Work From Home: Remote

Travel Percentage: 0%

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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