Sr. Staff AQE - Software in Kalamazoo, MI at Stryker Corporation

Date Posted: 9/25/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Kalamazoo, MI
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    9/25/2018
  • Job ID:
    31475BR

Job Description

The Software QA Technical Lead (Sr. Staff AQE) will lead quality efforts for Stryker’s Connected Care R&D software projects. The Sr. Staff AQE will also provide inputs to the software R&D team and process from a quality perspective, partner with vendors to drive execution of testing strategies, and drive continuous process improvements.  Select responsibilities include:

  • Provide guidance to the R&D software development teams through our internal quality system(s) process to ensure products are developed in compliance to procedures and other regulations (FDA/HIPAA/ISO).
  • Actively participate in defining and updating quality system software processes to support quality software as required in alignment with regulations for change control, data privacy, software development and security.
  • Review, execute or evaluate project documentation including validation plans/summaries with test script outputs to ensure we are delivering quality software. 
  • Collaborate with the development team, business analyst, external vendors and business partners to ensure quality software delivery. 
  • Work with leadership and team members to solicit process requirements and drive organizational change for continuous process improvements.
  • Function in an Agile (Scrum)/DevOps team while using ALM tools to help with defect tracking, traceability, release and build management efforts.
  • Lead test strategy definition to include UAT, functional, integration, performance, system testing with testing tools and test automation as appropriate.
  • Identify and partner with third party vendors to drive execution and results of testing strategies.
  • Share and educate the team on software quality best practices and processes (particularly agile and scrum).
  • Perform risk analysis and develop mitigation strategies as appropriate.
  • May conduct internal quality system audits and be involved with CAPA projects.

Minimum Education, Experience & Qualifications:

  • B.S. in Computer Science Engineering or Electrical Engineering or Engineering related discipline required. Knowledge of web and mobile application technologies is preferred.
  • 5 – 7+ year’s experience in a software engineering organization in a development or quality engineering role in a regulated environment.
  • Experience creating software processes for a regulated industry including SoP’s, Quality System documents and business processes.
  • Working knowledge of different SDLC’s (software development life cycle) particularly agile scrum/SAFe/DevOps model.
  • Working knowledge of different requirements management processes, testing strategies and tools, risk analysis, defect tracking, code review and release management processes.
  • Working knowledge of FDA (IEC 62304) and process validation (GAMP5 - CSV - Computer Systems Validation) regulations (HIPAA) and standards is preferred.
  • Knowledge of cloud based technologies (Microsoft Azure and SalesForce), data analytics and related technologies is preferred.
  • Excellent analytical and problem-solving skills.
  • Excellent interpersonal skills.
  • Excellent organizational skills
  • Strong verbal and written communication skills.
  • Experience with software medical device R&D and manufacturing processes preferred.
  • Experience with IT processes and systems preferred.

Demonstrated ability to:

  • Navigate execution of projects through processes, guidelines and procedures.
  • Review, identify and drive correction in outputs and documentation to maintain compliance.
  • Lead testing strategy definition, identify edge cases and review results to drive decisions.
  • Plan, organize and implement multiple, concurrent tasks.
  • Work with remote teams to drive execution and results.
  • Communicate with large groups of people; in person and telephonically.
  • Review printed materials
  • Use common office equipment (e.g. calculator, PC, fax machine, etc.).

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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