Job Description

Why join Stryker?

Looking for a place that values your unique talents? Discover Stryker's award-winning culture.

We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards - not to mention various social and recreational activities, all of which are location specific.

Job description

We are excited to be named one of the World's Best Workplaces by Fortune Magazine!


We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards - not to mention various social and recreational activities, all of which are location specific.

What you will do:

Design, develop, and maintain detailed test cases, checklists, and test data; Execute test cases for web, mobile, and desktop applications; Identify, document, and track defects using a bug-tracking tool (e.g., Jira). Perform different types of testing: Functional, Regression, Integration, System, Sanity, etc; Participate in review meetings, sprint planning, and daily stand-ups Develop and execute

validation strategies and plans

for new and existing computerized systems. Create and maintain validation documents including: User Requirements Specifications (URS); Functional Specifications (FS); Risk Assessment; Validation Plans (VP) ; IQ/OQ/PQ Protocols and Reports; Traceability Matrix. Perform impact assessments and

change control activities

for validated systems. Provide training and guidance on CSV processes and best practices. Maintain validation documentation in alignment with company procedures and regulatory expectations.

What you will need-

Required:

Experience- 2yrs to 5 years of experience in manual software testing and computer system validation within regulated industries (pharma, biotech, medical devices). Bachelor's degree in engineering, Computer Science, Life Sciences, or related field. Good understanding of SDLC, and defect life cycle; Experience with bug-tracking/project management tools (e.g., Jira, Devops); and validating systems such as Valgenesis, and custom applications.

Preferred :

Understanding of

software development life cycle (SDLC)

and

risk-based validation approaches;

CSV certifications (e.g., ISPE, PDA) or GxP training; ISTQB Certification Experience in data integrity assessments and remediation projects; Familiarity with cloud-based systems and cybersecurity considerations. Strong knowledge of

GAMP 5

,

21 CFR Part 11

,

Annex 11

. Excellent documentation, reporting, communication, and project management skills.
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. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.