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Stryker senior software quality engineer in Shirley, Massachusetts

The Senior Software Quality Engineer will be responsible for quality system support for R&D projects; generation and/or review of software documentation; provide inputs to software R&D designs; support test strategies for software systems; improve quality processes as they apply to software systems. 

· Responsible for the complete life cycle of a new/modified software product, from research and design to implementation, training and support.

· Support development of software solutions by studying information needs; conferring with users; studying systems flow, data usage, and work processes; investigating problem areas; by developing documentation, flowcharts, layouts, diagrams, charts, code comments and clear code while following the software development lifecycle.

· Partner with cross functional project teams to lead product and/or process planning, design and development activities

· Partner with Product Development to define requirements that will ensure appropriate level of rigor to software validation

· Support Risk Management activities throughout the product development life cycle. Perform formal risk analysis, develop software risk control measures and mitigations, and create SFMECA in support of risk management.

· Partner with Product Development to perform risk evaluation of product design and to define design verification and validation test requirements that will ensure appropriate objective evidence is available to support the acceptance criteria

· Provide support to the development team through Software Development and New Product Development process including demonstrating understanding of software lifecycle methodologies (e.g. Waterfall, Agile).

· Responsible for Software test and quality assurance including software verification strategies, test scripts and traceability to requirements.

· Develop quality assurance documentation to support regulatory submissions

· Analyze reports and defective products to determine trends and recommend corrective actions.

· Collaborate with supplier representatives on quality problems to ensure that effective corrective actions are implemented and contribute to supplier quality improvement programs.

· Support quality system maintenance for the division by identifying and correcting deficiencies in our procedures and practices

· Lead and/or assist in resolving nonconformities and corrective actions/preventive actions (CAPA)

· Participate in internal and external compliance audits


Work From Home: Occasional

Travel Percentage: 10%

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.

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at