Staff Quality Assurance Engineer in Portage, MI at Stryker Corporation

Date Posted: 1/29/2020

Job Snapshot

Job Description

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Staff Quality Assurance Engineer located in Kalamazoo, Michigan 

Who we want:

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

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.

Teammates. Partners who listen to ideas, share thoughts and work together to move the business forward.

Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

What you will do:

Responsible for the identification of potential failure modes and risks, and the development of quality assurance practices and controls in new product development. Knows and applies broad knowledge of principles, practices and procedures within advanced quality specialization in the completion of difficult assignments. Collect, interpret, and determine the root cause of failures

  • Develop the quality report
  • Develop and communicate the reliability and warranty goal to Center for new products
  • Resolve testing corrective actions and determine the necessary corrective and preventative actions
  • Conduct design reviews and track all findings
  • Manage and track all software issues
  • Participate in software requirement specification and software design document reviews, and code reviews as needed
  • Conduct risk analyses and track all findings
  • Release customer preference test and customer confirmation test units for shipment
  • Develop the risk management portfolio
  • Conduct audits as specified by the divisional schedule and as determined by new product development needs
  • Conduct software quality assurance plan audits to verify development practices conform to procedures
  • Review software configuration management to verify its practices conform to procedures
  • Develop quality-related specifications and tests
  • Write safety, durability, craftsmanship, and reliability design input specifications from Quality report, design reviews, risk analyses, and customer research
  • Develop statistical rationale for testing
  • Develop the rationale for validation sample size, duration, and number of locations
  • Create and maintain software traceability matrix to track all requirements to closure
  • Develop and maintain black box test scripts
  • Assist and develop process controls
  • Implement internal detective process controls
  • Specify which preventative and detective controls are required, and communicate to vendors
  • Verify gage repeatability, reproducibility, and accuracy, and address deficiencies
  • Develop and document the inspection methods
  • Develop the budget and schedule for process controls
  • Validate vendor-implemented process controls
  • Perform software first article inspection
  • Perform tool validation for off-the-shelf and custom test fixtures
  • Perform validation of software-controlled production test system / equipment
  • Prepare product and operations for transition
  • Train quality assurance engineers and inspectors
  • Handle quality assurance engineering responsibilities after launch
  • Prepare risk management portfolio for long term maintenance by the QAE
  • Advanced Responsibilities
  • Has appreciable latitude for unreviewed action or decisions.
  • Usually works with general supervision, conferring with superiors on unusual matters
  • Viewed as a departmental resource in area of expertise
  • May direct work of Engineer or Sr. Engineer

What you need:

  • Bachelor’s Degree in Software Engineering or Electrical Engineering
  • Minimum of 4-6 years’ work experience in a relevant field
  • Achieved a working (applying) level of industry knowledge
  • Competent with Microsoft Office (Outlook, Excel, Word, etc.)
  • Must possess excellent oral and written communication skills
  • Ability to solve problems in a high stress situation
  • Possess attention to detail
  • Eagerness to assist internal and external customers
  • Manage projects in a timely manner
  • Ability to conduct and document technical investigation
  • The following experiences/skill sets are preferred (ISO 13485 and ISO 14971Industrial statistical techniques, development and implementation of design and process controls GD&T)

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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