Senior Quality Systems Manager

The Opportunity

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.

The Quality Systems Manager will be hands-on and drive the implementation and refinement of the quality management system designed to be aligned with FDA 21 CFR 820 and ISO 13485:2016. This position requires a willingness and aptitude to tackle a wide range of challenges, with the ability to internalize the complexities of Bethyl’s business, Fortis’ goals and objectives as well as those of other portfolio companies. This key individual will provide support involving product design and development, product testing and disposition, quality investigations and cGMP oversight to product manufacturing, evaluation, and release. As deemed necessary, the Quality Systems Manager may be required to perform other duties not listed on the essential responsibilities.

Essential Responsibilities:

The Quality Systems Manager will report to the Director of QA/RA and may be required to perform all or a combination of the following essential responsibilities:

• Assist in establishing and maintaining quality systems, policies, procedures and controls
• Ensure product quality aligns with regulatory requirements and company standards
• Act as the primary business owner/administrator for the eQMS system
• Work with internal teams to ensure compliance with DHFs, DMRs, DHRs for regulated products
• Manage operational quality: change control, NCM, root cause analyses, CAPA, quality records
• Responsible for the complaint handling process, including receipt, investigation and closure
• Plan and manage audits (internal and external) using risk-based assessments, reporting findings and implementing appropriate risk escalation and mitigation strategies
• Manage training program, including training plans/schedules, cGMP, new hire QMS overview
• Ensure product quality aligns with regulatory requirements and company standards
• Support Operations with SQA; qualify new suppliers and routinely monitor supplier quality
• Manage/perform software validations aligned with Part 11/GAMP 5
• Manage and provide quality data to assist in risk management and risk-based decisions
• Collect and report on quality metrics via Quality Management Reviews
• With Quality leader and site leadership, assist in hosting customer requested audits
• Provide data, trending and detailed analyses to support daily quality management
• Manage quality system requirements, acceptance activities, and document controls
• Perform product labeling reviews/approvals
• Assist in promoting and advancing a Quality Culture

Experience & Training:

• Bachelor’s degree (required), Sciences or Engineering degree preferred
• At least 5 years of Quality experience required in life science or medical device industry
• ASQ CQA, CQT, CQE, or CMQ/OE certification a plus
• Knowledge and understanding of 21 CFR 820, ISO 13485:2016, and ISO 14971 processes
• Experience or knowledge with process or software validations a plus
• Proficiency with Microsoft Office suite; familiarity with eQMS desired
• Internal, external, or customer audit experience
• Be driven, collaborative, energetic, with high personal integrity
• Excellent written/verbal communication, presentation, project management skills
• Able to manage multiple priorities and ability to consistently meet deadlines
• Strong analytical and problem-solving skills with attention to details.

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.