Carestream · 17 hours ago
Senior Quality Assurance Engineer
Rochester, NY
Full-time
Onsite
Senior Level
5+ years expCarestream is a company that specializes in providing solutions for the Non-Destructive Testing industry. They are seeking a Senior Quality Assurance Engineer responsible for system test design, planning, and oversight of test execution on a variety of system products, ensuring compliance with regulatory requirements and leading product design teams through verification activities.
Responsibilities
Responsible for supporting design verification of new product design, development, and transfer of the resultant design to manufacturing along with process compliance to regulatory requirements
Contributes to new product development/manufacturing in areas of design verification & validation of product requirements, regulatory requirements, specification development, measurable outcomes, hazard and safety analyses and other quality activities necessary to meet project objectives in the hardware/software/manufacturing arenas
Leads product design teams through system Failure Mode Effects Analysis (FMEA) activities
Creates and executes test plans
Develops schedules/resource plans for the verification and validation portion of a product design project
Documents and delivers to the appropriate repository all test results, analysis, and test summary reports
Represents customer perspective in project quality decisions
Provides clear scope definition, implements new tools, drives change management, and defines metrics that define successful completion
Supporting Regulatory agency audits and inspections
Leads verification activities related to design change activities including testing assignments on updates to existing products
Duties may include leading cross-functional corrective action team(s) or projects
Duties may include activities to support the customer complaint process
Duties may include supplier quality and audit activities
Qualification
Required
Bachelor's degree in Engineering (electrical or mechanical) or any STEM program
Min 5 years of demonstrated engineering skills
Ability to provide direction to and apply statistical tools
Demonstrated data-driven decision making
Ability to influence within peer group and higher management
Excellent attention to detail
Leadership skills
Strong analytical, decision-making and problem-solving skills
Excellent written and verbal communication
Preferred
Quality Engineering, manufacturing or service experience within an ISO and/or FDA regulated medical device industry
Knowledge of industry standards such as AWS, ASME, API (510, 570, 1169)
Working knowledge of MIL specs and NDE methodologies
Competent in the use of statistical software (ex. Minitab, Reliasoft, etc)
ASQ Certification (CQE, CRE), Six Sigma Black Belt or Green Belt Certification
Competent in the use of quality tools (ex. Reliability, FMEA, fault tree analysis, root cause analysis, fishbone diagrams, DOE, ANOVA, Cpk, etc)
Company
Carestream
CareStream provides imaging and IT systems for sectors ranging from medical and life sciences research to advanced materials production.
1001-5000 employees
H1B Sponsorship
Carestream has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (2)
2023 (1)
2022 (4)
2020 (1)
Funding
Current Stage
Late StageTotal Funding
$2.4B2013-06-12Debt Financing· $2.4B
2007-05-02Acquired
Leadership Team
Todd Clegg
Chief Executive Officer
Recent News
2025-11-05
Carestream Health
2025-10-03
Company data provided by crunchbase