Senior Staff Software Advance Quality Engineer (REMOTE) at Stryker

Portage, Michigan, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, TechnologyIndustries

Requirements

Bachelor’s 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

Responsibilities

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
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

Skills

Azure

AWS

SOC 2

ISO 27001

FDA 21 CFR Part 11

HIPAA

ISO 13485

SDLC

SaaS

Software Quality Assurance

Audits

Change Control

Cloud Validation

Stryker

Develops and manufactures medical devices and equipment

About Stryker

Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.

Kalamazoo, MichiganHeadquarters

1941Year Founded

$423.3MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Medical & prescription plans

Supplemental health benefits

Flexible Spending accounts

Employee Assistance Program

Short-term & long-term disability

Tuition reimbursement

401(k) plan

Employee Stock Purchase Plan

Risks

Integration challenges from acquisitions may strain Stryker's resources.

Rapid tech advancements risk obsolescence of Stryker's current products.

Regulatory scrutiny on acquisitions could delay Stryker's market entry.

Differentiation

Stryker's acquisitions enhance its minimally invasive surgical solutions portfolio.

Entry into the peripheral vascular segment diversifies Stryker's market presence.

Stryker's focus on AI integration boosts diagnostic accuracy and operational efficiency.

Upsides

Growing demand for minimally invasive solutions aligns with Stryker's strategic acquisitions.

The orthopedic implants market growth benefits Stryker's expanding product line.

Stryker's acquisition of Inari Medical positions it in a high-growth vascular market.

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