Systems Quality Engineer

Compensation: $90,000 - $120,000 per year

• This range reflects Carestream's good faith estimate to pay fairly as starting wage. Offers will be tailored within the range based on the selected candidate's experience, industry knowledge, technical and communication skills, and other factors that may prove relevant during the interview process, as well as geographic market differentials for the position.

Position Summary

We are looking for an energetic individual who wants to be part of a growing, entrepreneurial company that is committed to delivering high quality medical products, services, and solutions that meet radiology customers' needs. Our employees drive our innovation and success by contributing to cross‑functional projects that enable them to show their potential, ability to stretch, and their growth. Hard work, talent, and proactively demonstrating results are rewarded by career development and advancement opportunities.

The individual will be part of the Research and Development Engineering team with contributing responsibility for the verification and validation of new products being developed. This person plans, designs and executes complex schedules and test plans, as well as hazard and safety analysis, per the specifications, while adhering to all policies and procedures. They ensure outcomes are measured, data is tracked accurately, and proper documentation meets all compliance requirements. This person also leads and coaches quality engineering team members providing guidance on projects, procedures, and testing.

Position 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 analysis and other quality activities necessary to meet hardware/software project objectives. Develop complex schedules/resource plans for Verification and Validation activities. Plan, design, and execute complex test plans and procedures for Verification and Validation activities. Document all quality deliverables in the appropriate repository. Represent customer perspective in project quality decisions. Provide clear scope definition, implement new tools, drive change management, and define metrics that indicate successful completion of Verification and Validation activities. Provide support for regulatory agency and internal audits and inspections. May also support the customer complaint process. Required Skills & Education 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. Desired Skills 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 (e.g. ADO/MR, PLI, MasterControl, reliability related, FMEA, fault tree analysis, root cause analysis, fishbone diagrams, DOE). Ability to provide direction for and apply statistical tools to support Verification & Validation activities (e.g. Minitab, Reliasoft). Demonstrated knowledge with various automation tools/environments/languages including but not limited to Robot Framework, GIT, Python, Java, Fish/Eye/Crucible, Ghost.

Carestream is an Equal Opportunity Employer

Carestream is an equal opportunity organization. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, gender identity, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

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