Senior Staff Software Advance Quality Engineer (REMOTE)
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Job Location:
Portage, WI - USA
Monthly Salary:
$ 115600 - 245800
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Senior Staff Software Quality Assurance Engineer - Remote
Stryker is seeking a Senior Staff Software Quality Assurance Engineer to support our Digital Robotics and Enabling Technologies business by driving quality this role you will partner with R&D software development teams to guide them through internal quality system processes and ensure compliance with internal procedures and regulatory standards (e.g SOC 2 ISO FDA and HIPAA)
What you will do:
- Support software product teams by guiding them through internal quality processes and documentation requirements.
- Participate in risk assessments quality document reviews design review and change control processes to ensure quality impacts are considered and addressed.
- Ensure development activities align with applicable regulatory and compliance frameworks (e.g. SOC 2 ISO 27001 FDA 21 CFR Part 11 HIPAA ISO 13485).
- Lead SOC 2 compliance activities and support internal and external audits.
- Support internal and external SOC2 audits
- Ensure that cloud system validation and software lifecycle deliverables meet applicable standards and company policies.
- Collaborate with leadership and cross-functional teams to identify process gaps and implement continuous improvements across the SDLC
- Maintain and improve quality system documentation including SOPs work instructions and guidance documents.
What you will need:
Basic Qualifications:
- Bachelors degree in Software Engineering Computer Science or a related field.
- 6 years of experience in software quality or quality systems role supporting cloud-based or SaaS products.
- Strong understanding of software development lifecycles (SDLC) and how quality assurance fits into each stage
- Experience with cloud platforms preferably Microsoft Azure or AWS
- Knowledge of SOC 2 ISO HIPAA FDA or other related regulatory standards
- Solid understanding of quality systems audits software change control and statistical analysis
Preferred Qualifications:
- Knowledge of AICPA SOC 2 certification requirements or equivalent standards.
- Certifications such as Software Quality Engineer (CSQE) or equivalent.
- Experience with the medical device product development lifecycle.
$115600 - $245800 salary plus bonus eligible generally eligible for short-term and long-term financial incentives benefits. Individual pay is based on skills experience and other relevant factors.
Posted: October 29 2025
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 contractors legal duty to furnish information.Required Experience:
Staff IC
Key Skills
- Design
- Illustration
- Automotive
- Drafting
- Android Development
- Application Support
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more
