QA Engineer, Quality Risk Management at Fujifilm

Holly Springs, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Jun, 26

Salary

0.0

Posted On

06 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Risk Management, FMEA, HACCP, Risk Assessment, CAPA, ISO 9001, ISO 13485, ICH Q9, ISO 14971, cGMP, Validation, Change Control, Risk Registers, Data-Driven Decisions, Process Improvement, Quality Culture

Industry

Chemical Manufacturing

Description

Position Overview The QA Engineer, Quality Risk Management, drives the design, implementation, and continuous improvement of risk-based quality systems across the product lifecycle. The role facilitates structured risk assessments (e.g., FMEA, HACCP), translates risk outputs into controls, verification/validation plans, and monitoring strategies, and maintains risk registers and quality risk metrics. It partners cross-functionally with Manufacturing/Operations, Supply Chain, and Regulatory to enable compliant, data-driven decisions, effective change control, and prioritized CAPA. This position exists to proactively identify, quantify, and mitigate quality risks to safeguard patient/customer safety, ensure product reliability, and maintain compliance with applicable standards and regulations (e.g., ISO 9001/13485, ICH Q9, ISO 14971). Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers Job Description What You’ll Do Leads and facilitates Quality Risk Management (QRM) assessments and workshops to identify, analyze, and address key quality risks/issues; ensures timely escalation and effective risk handling. Identifies and assesses risks across operations, designs mitigation strategies, prioritizes risk actions, and communicates progress and outcomes at defined stage gates to drive timely decisions. Builds relationships and initiates cross-functional collaboration with key counterparts and stakeholders across FLBN to surface quality risks and define process improvement initiatives. Collaborates with and provides direct support to Manufacturing, Facilities, Supply Chain, QC Laboratory Testing, and other stakeholders to implement and sustain QRM processes within established work practices. Ensures consistent application of QRM system requirements in alignment with local/global procedures, policies, and applicable regulatory standards (e.g., cGMP). Prepares and delivers comprehensive reports on QRM activities; maintains risk registers and quality risk metrics to enable transparent, data-driven decision-making. Creates and maintains procedures, work instructions, forms, templates, and related QRM documentation to standardize practices and enhance compliance. Manages multiple QRM projects concurrently, balancing scope, priorities, and timelines to meet deliverables. Promotes a strong Quality Culture by reinforcing cGMP principles and best practices across departments. Minimum Requirements: BS/BA in Life Sciences or Engineering or equivalent with 5+ years of applicable industry experience OR MS in Life Sciences or Engineering and 3+ years of applicable experience OR PhD in Life Sciences or Engineering and 1+ years of applicable experience 3+ years of experience in a GMP environment Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility. High level of familiarity/understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and methodologies Preferred Requirements: Experience and working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software Experience with startup projects or initiatives Working Conditions & Physical Requirements: Ability to ascend or descend ladders, scaffolding, ramps, etc. x No Yes Ability to stand for prolonged periods of time. No x Yes Daily up to 120 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)Ability to sit for prolonged periods of time. No x Yes Daily up to 120 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers. No x Yes Ability to operate machinery and/or power tools. x No Yes Ability to conduct work that includes moving objects up to X pounds. No x Yes If yes, x 10 lbs. 33 lbs. Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. x No Yes To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).

Responsibilities

This role drives the design and continuous improvement of risk-based quality systems across the product lifecycle, facilitating structured risk assessments and translating outputs into mitigation strategies and monitoring plans. The engineer partners cross-functionally to ensure compliant, data-driven decisions, effective change control, and prioritized Corrective and Preventive Actions (CAPA).