Carestream · 8 hours ago
Systems Quality Engineer
New York,United States
Full-time
Onsite
Mid, Senior Level
$90K/yr - $120K/yr
4+ years expCarestream is a worldwide provider of medical imaging systems and solutions, and they are seeking a Systems Quality Engineer to contribute to the verification and validation of new products. The role involves planning, designing, and executing test plans while ensuring compliance with regulatory requirements.
Medical Device
Responsibilities
Responsible for supporting new product development and process compliance to regulatory requirements. Also responsible for (but not limited to) the following:
Contribute to new product development 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 hardware/software project objectives
Develops complex schedules/resource plans for Verification and Validation activities
Plans, designs, and executes complex test plans\procedures for Verification and Validation activities
Documents in the appropriate repository all quality deliverables
Represents customer perspective in project quality decisions
Provides clear scope definition, implements new tools, drives change management, and defines metrics that define successful completion of Verification and Validation activities
Provides support for Regulatory agency and internal audits and inspections
Duties may also include activities to support the customer complaint process
Qualification
Required
Bachelor's degree in engineering (electrical, mechanical, software, cybersecurity, etc.), Imaging Science, or the Clinical domain (preferably in engineering for medical devices) or equivalent
4+ years (6-10 years preferred) of demonstrated engineering skills and leadership in software and hardware quality roles
Demonstrated data-driven decision making
Excellent attention to detail
Demonstrated leadership skills
Strong analytical, decision-making and problem-solving skills
Excellent written and verbal communication
Preferred
Quality Engineering, manufacturing, or service experience within a regulated medical device industry
Experience with regulatory audits (ISO 9001, ISO 13485, MDSAP, etc.)
Quality, Security, AI related certifications (Six Sigma Black Belt or Green Belt, CSQE, CQE, CRE, CISSP, Prompt Engineering, etc.)
Competent in the use of quality and implementation tools (ex: ADO/MR, PLI, MasterControl, Reliability related, FMEA, fault tree analysis, root cause analysis, fishbone diagrams, DOE, etc.)
Ability to provide direction for and apply statistical tools to support Verification & Validation activities (ex. Minitab, Reliasoft, etc.)
Demonstrated knowledge with various automation tools/environments/languages including but not limited to Robot Framework, GIT, Python, Java, Fish/Eye/Crucible, Ghost
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