Senior Quality Engineer

Stryker – Redmond, WA

Who we want
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.
Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

User-focused creators. People who imagine with the user in mind, developing technology that helps change patients lives.

What you will do

As a Senior Quality Engineer, you will design, develop, and implement policies and procedures for the maintenance, compliance and enhancement of quality and reliability standards of currently manufactured or procured components, sub-assemblies and products. This includes production processes and techniques, quality engineering procedures and techniques, and regulatory compliance. Design and supervise construction, verification, documentation and application of custom inspection and test equipment. Monitors products, processes and projects and recommends changes to improve operating efficiency. Responsibilities relate to all products manufactured by Physio-Control.

Responsibilities:

  • Provide ownership of issues related to manufacturing and supplier quality through the Corrective Action and Preventive Action (CAPA) process
  • Provide manufacturing, validation and process failure mode effects analysis support
  • Assures compliance to in-house and/or external specifications and standards, such as GMPs and ISO regulations
  • Represents quality on various business teams to support product and process improvement.
  • Plan, write, modify and assist in the implementation of quality and reliability requirements and procedures within the manufacturing area of Physio-Control.
  • Performs analysis and identifies trends in finished products, in-process materials and recommends corrective actions and process improvements.
  • Establish plans for improvement of quality and reliability to meet product objectives. Coordinate activities of Engineering, Manufacturing and Quality Assurance.
  • Establish test protocols to evaluate manufacturing process changes for safety, quality, reliability, and regulatory considerations.
  • Plan and schedule quality and reliability activities such product or process audits, Quality Engineering systems activities, agency certification, computer software, and test equipment and test protocol.
  • Provide consultation on test equipment and failure analysis.
  • Provide direction to other departments to ensure that workmanship standards, acceptance criteria, and general quality policies are met.
  • Provide technical direction to Manufacturing in development of training, certification, audit and other programs in support of manufacturing.
  • Perform other related duties as assigned.

What you need

Basic Qualifications:

  • Bachelors Degree in Engineering
  • Minimum 5 years experience in quality, manufacturing and/or engineering.

Preferred Qualifications:

  • Bachelors Degree in Electrical, Mechanical, Industrial or Biomedical Engineering field preferred.
  • Proficient use of electrical, mechanical or environmental procedures, quality control testing equipment and methods.
  • Demonstrated proficiency in project management with leadership skills.
  • Experience in the DMAIC process, six sigma or design for six sigma.
  • Strong quality background, CQE preferred.
  • Strong analytical skills using statistical methods of problem analysis.
  • Strong technical writing and verbal communication skills.

Working Conditions:

  • Fast-paced office and manufacturing environment; significant use of computer monitor, keyboard, and mouse.
  • Minimal travel may be required (less than 10%).

Work From Home: No

Travel Percentage: None

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 contractors legal duty to furnish information.

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