QA Engineer

We are hiring a Quality Assurance Engineer. The Quality Assurance Engineer will lead Quality System improvements as well as drive resolution of deviations and product nonconformance.

The role involves identifying and implementing efficiencies, leading risk assessments, managing quality-related customer support, and ensuring compliance with ISO 9001 requirements.

Oversee and ensure that required quality exists in all Quality Assurance & Validation functions as prescribed by the ISO 9001 and applicable standards / regulations.

Responsibilities :

• Perform and assist with incoming inspection, batch records, documentation, training, batch release, validation, deviation, complaint, investigation, continuous improvement, and system reviews
• Assist with document creation, revision, issuance, and training
• Support internal, customer, supplier, and regulatory audits
• Review and release raw materials, intermediates, and final products
• Lead and execute validation activities
• Manage trend reviews, data reviews, KPI management, and continuous improvement projects
• Assess, investigate, and verify information related to non-conformances
• Drive continuous improvement within the organization, particularly concerning non-conformance CAPA (corrective and Preventative Actions), audit observations, complaints, and other quality datasets
• Act as customer liaison for internal inquiries and provide the voice of the customer
• Coordinate and complete customer surveys, questionnaires, and audits
• Support supplier questionnaires and qualifications
• Support change notifications and supplier management
• Other duties as assigned

Required Skills / Education :

• High school diploma or equivalent; basic understanding of mathematics and chemistry necessary
• Two years of college in a science discipline is preferred
• A minimum of two (2) years of Quality Assurance in medical device manufacturer or equivalent
• Proficiency in current versions of WordPerfect, MS Word, Excel, Outlook
• Current industry regulations, i.e. Detailed understanding of 21CFR211-cGMP, FDA QSR 820, ISO13485 : 2003, Canadian Medical Device Regulations and inspection and auditing guidelines
• Ability to speak, read, and write English
• Good Oral and communication skills

Desired Skills :

• Statistical Analysis
• Process Improvement
• Project Management
• Qualification / Validation (IQ / OQ / PQPV)

LI-AA1

Fujifilm is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by federal, state, or local law.

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.