KCS Group

Senior QA/ Testing Engineer   




  Stryker Corpoation - Redmond, Washington is looking for Senior QA/ Testing Engineer



Job Description

Candidate should have a Bachelor s degree in Science, Engineering, or related discipline (Electrical, Mechanical, Industrial, or Biomedical preferred) with 2+ years of experience in quality, manufacturing, and/or engineering.

Preferred Qualifications-

Knowledge of medical device manufacturing processes, ISO 13485, and GMP standards.
Lean Six Sigma training or certification.
Experience with risk management, CAPA, audits, and statistical techniques.
Familiarity with regulatory agencies (FDA, MoH, TUV) and compliance requirements.
High level knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.

Job Responsibility-

Ensure quality performance of products and processes across operations and business functions.
Manage internal and supplier-driven non-conformances, ensuring timely investigation and closure.
Own corrective and preventive actions (CAPAs) through root cause analysis and resolution.
Review and approve change management activities, driving effective implementation and continuous improvement.

Analyze KPI trends and lead initiatives to optimize manufacturing processes and reduce waste.
Support process and equipment validation, qualification, and measurement system analysis (MSA).
Provide quality assurance support during internal and external audits to maintain compliance.
Advocate for human factor practices and apply risk management principles to manufacturing operations.

$88,800.00 - $142,300.00 salary plus bonus eligible + benefits.
Individual pay is based on skills, experience, and other relevant factors.
 

Work Experience

2 to 5 Years

Level

 Middle / Assistant Manager 


Job Function
IT-Software, Software Testing, Quality Control/Assurance


Vacancies
Not Specified 


Industry
Biotechnology/Pharma 


Job Location
Hybrid, Redmond, WA, United States 


Educational Qualification
BCA/BCS, B.E./B.Tech, M.Tech, MCA/PGDCA


Salary
Not Specified


Key Skills
Quality Assurance, Risk Management, CAPA, Audits, and Statistical Techniques


Company Info
Stryker is one of the world s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. At Stryker, quality is first in everything we do. We are driven to make healthcare better for our customers by providing innovative products and services that meet regulatory requirements through our effective quality system.

At Stryker, we don t only care about where you`ve been; we`re invested in where you`re going. Our dynamic career opportunities are designed to let you explore new horizons without the need to look beyond our doors. "We grow talent" isn`t just a saying around here it`s our commitment. It means we`re dedicated to nurturing your strengths, opening doors to new challenges and supporting your professional journey.
 


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