3599 IT & Software Developer jobs in the US
Senior Engineer, Quality Assurance
$89,400 - 148,900
Stryker
Engineering Court 314, Irvine
$89,400 - 148,900
Requirements
Must:
- Bachelors degree in engineering
- At least 2 years of experience in quality, engineering, validation, or a highly regulated environment.
- Preferred: Engineering degree in Mechanical, Electrical, Chemical, or Biomedical Engineering.
- Preferred: 2+ years of experience in quality, engineering, validation, or regulated manufacturing sectors.
- Preferred: Experience supporting R&D, New Product Development (NPD), New Product Introduction (NPI), or Commercial Operations activities.
- Preferred: Familiarity with ISO 13485, GMP, GDP, and medical device manufacturing processes.
Responsibilities
- Provide quality and validation engineering support to guarantee compliance with relevant regulations, standards, and internal procedures.
- Champion quality initiatives aimed at preventive measures, continuous improvement, and risk mitigation across products and processes.
- Supervise, review, and authorize Non-Conformances (NCs), CAPAs, and root-cause investigations while mentoring teams in structured problem-solving approaches.
- Support and validate change management actions, ensuring thorough risk assessment and regulatory adherence.
- Offer subject-matter expertise for process, equipment, and computer system validation/qualification, including the review and approval of validation documents.
- Actively engage in the development and refinement of manufacturing processes for both existing and new products.
- Assist in the execution, analysis, and review of Quality Acceptance Tests (QATs) and First Article Inspections.
- Lead and engage in risk management practices, utilizing tools such as FMEAs, FTAs, and other risk-based strategies.
- Serve as site owner for at least one validation specialty, acting as the main technical resource and validation liaison.
- Interact with internal and external auditors and regulatory bodies, delivering concise and effective technical narratives in your area of expertise.
- Collaborate across departments to ensure that quality and validation perspectives are seamlessly integrated into operational and project decisions.
Description
At Stryker Corporation, we are dedicated to advancing medical technology and ensuring the highest quality in our products and processes. Our team is committed to fostering a collaborative environment where individuals can thrive and grow. We offer competitive salaries ranging from $89,400.00 to $148,900.00 USD annually, alongside a bonus opportunity and comprehensive benefits. This is an onsite position with a travel expectation of around 10%. We uphold equal opportunity employment and embrace diversity in our workforce.
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The company with most openings is Judge Group, Inc. as they are hiring for 254 different QA, Test Engineer jobs in the United States. They are probably quite committed to find good QA, Test Engineers.
The company with most openings is Judge Group, Inc. as they are hiring for 254 different QA, Test Engineer jobs in the United States. They are probably quite committed to find good QA, Test Engineers.