Senior Staff, Software Quality Assurance Engineer

Stryker

Weston, FL

Full Time

Senior

8 days ago

Job Description

About the Role

Stryker is seeking a Senior Staff Software Quality Assurance Engineer to support our Digital Robotics and Enabling Technologies business by driving quality processes. In this role, you will partner with R D software development teams to guide them through internal quality system processes and ensure compliance with regulatory standards, including FDA, HIPAA, ISO, and SOC 2.

Key Responsibilities

Lead SOC 2 compliance activities and support internal and external audits.
Define and update quality system software processes to ensure compliance with regulations related to change control, data privacy, software development, and security.
Present product-related risks during design reviews and oversee mitigation throughout the product lifecycle.
Influence new product development by defining design verification and validation test requirements to ensure compliance with design inputs and regulatory standards.
Perform risk analyses and develop appropriate mitigation strategies.
Collaborate with leadership and cross-functional teams to gather process requirements and drive continuous improvement.
Conduct internal quality system audits and contribute to CAPA (Corrective and Preventive Action) initiatives.
Work within Agile (Scrum)/DevOps environments using ALM tools for defect tracking, traceability, and release/build management.

Requirements

Bachelor's degree in Software Engineering, Computer Science, or a related field.
6+ years of experience in software development or quality engineering roles.
Working knowledge of the Software Development Life Cycle (SDLC) and proficiency in Agile, Scrum, SAFe, and DevOps methodologies.
Experience with cloud platforms, preferably Microsoft Azure or AWS.
Knowledge of SOC 2, ISO, HIPAA, FDA, or other related regulatory standards.
Proficient in Agile, Scrum, SAFe, and DevOps software development methodologies.
Solid understanding of quality systems, including CAPA, audits, and statistical analysis.

Nice to Have

Knowledge of AICPA SOC 2 certification requirements or equivalent standards.
Familiarity with GAMP 5, Computer System Validation (CSV), and process validation.

Qualifications

Educational background includes a Bachelor's degree in Software Engineering, Computer Science, or a related field.

Benefits & Perks

Medical and prescription drug insurance
Dental insurance
Vision insurance
Critical illness insurance
Accident insurance
Hospital indemnity insurance
Personalized healthcare support
Wellbeing program and tobacco cessation program
Health Savings Account (HSA)
Flexible Spending Accounts (FSAs)
401(k) plan
Employee Stock Purchase Plan (ESPP)
Basic life and AD&D insurance
Short-term disability insurance

Working at Stryker

Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. The company impacts more than 150 million patients annually and values diversity and inclusion, being an equal opportunity employer that considers applicants without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.

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