Job Description

Fortis is a global leader in life sciences and diagnostics reagents and solutions. We partner with our customers to design, validate, and manufacture solutions to solve their complex development problems. Our teams work together across various sites, functions, & scientific disciplines to help our customers bring their innovations to market with confidence.

What You Will Do:

As a Quality Analyst II, you will play a critical role in maintaining and improving our Quality Management System (QMS) to meet ISO 13485, FDA regulations, and industry standards. You’ll work cross-functionally with R&D, Manufacturing, and Regulatory teams to enhance product quality, compliance, and operational efficiency. This is on onsite position at our offices located in Montgomery, Texas.

Key Responsibilities:

• Maintain and improve the QMS in compliance with ISO 13485, FDA 21 CFR Part 820, and other regulations.
• Participate in internal and external audits to ensure regulatory compliance and drive process improvements.
• Assist with regulatory submissions and product approvals, contributing to global market access.
• Oversee document control (e.g., Document Change Orders, DCO Logs) and ensure records comply with regulatory standards.
• Support product testing and validation to ensure product safety and efficacy.
• Collaborate on risk management initiatives to enhance quality and reduce potential compliance risks.
• Work closely with R&D, manufacturing, and operations teams to ensure compliance throughout the product lifecycle.
• Support the training program, ensuring employees stay up-to-date on quality and regulatory requirements.
• Identify opportunities for process improvement, increasing efficiency and compliance effectiveness.
• Other duties as assigned

Who You Are & What You Bring

Education / Background

• Bachelor’s degree in a relevant field (Biomedical Engineering, Life Sciences, Regulatory Affairs, or equivalent experience).
• 1+ years of experience in QA/RA within the medical device or IVD industry.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and regulatory requirements.
• Experience with regulatory submissions & approvals, are a plus.
• Familiarity with risk management principles in a production environment.
• Proficiency in eQMS, Microsoft 365, and other quality management tools.

Knowledge, Skills, Abilities:

• Excellent attention to detail, problem-solving skills, and organizational abilities.
• Ability to work independently and collaboratively in a dynamic team environment.
• Strong technical writing and analytical skills.

What We Offer

We have an incredibly talented group of intelligent, down-to-earth individuals who are committed to developing and manufacturing only the highest quality products. Our mission: “Pursuing a Healthier World by Creating Tomorrow’s Science Today” is complemented by our core values ( EXCITE ):

Excellence – We believe in solving for root cause. No shortcuts, no “band-aids”

Customer First – We prioritize the experience and outcomes of our customers above all.

Integrity – We are honest and accountable, holding ourselves to a high standard of ethical conduct.

Trust – We believe an engaged, empowered team begins with a foundation of trust. We trust our team members to make the right decisions and to be driven by and evaluated on results.

Entrepreneurship – We encourage smart risk taking. We value novel mistakes in the pursuit of innovation.

Fortis provides a competitive salary, success-sharing bonus plan, medical, dental, disability and life insurance, and a 401(k) plan. We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. We are an E-Verify Employer in the United States.

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