The Role

We’re hiring a Quality Systems Manager responsible for leading the development and improvement activities associated with the Company Quality Management System in accordance with FDA QSR, ISO 13485, ISO 14971, and other In Vitro Diagnostic Medical Devices guidelines and regulations.

Position: Quality Systems Manager

Location: West Lafayette, Indiana

Employment type: Full-Time

Key Responsibilities:

include but are not limited to the following:

• Utilize the company’s electronic Quality Management System (eQMS) to ensure full implementation of

quality and manufacturing processes.

• Provide Quality System expertise and support to the broader organization.

• Develop and maintain organized records that demonstrate compliance with company processes,

regulations, and the QMS.

• Serve as the primary point of contact for Laboratory Operations activities, including non-conformances

(NCRs), supplier management, and corrective/preventive actions (CAPAs/SCARs).

• Lead improvement projects initiated from non-conformances, audit findings, and customer complaints.

• Support routine Quality processes, including document control, employee training, and the tracking of

quality metrics.

• Prepare and report QMS metrics for Management Review.

• Participate in internal and external audits, including preparation, management, and post-audit follow-up.

• Maintain a constant state of inspection readiness and represent the Quality department in cross-

functional meetings.

• Comply with all personal protective equipment (PPE) requirements for the BSL-2 laboratory

environment.

Qualifications:

• Education: Bachelor’s degree in Engineering, Biology, or a related scientific discipline.

• Regulatory Knowledge: Extensive knowledge of medical device/IVD regulations (FDA 21 CFR 820, ISO

13485, ISO 14971).

• Experience: Proven track record in the medical device or biotechnology industry; Certified Quality

Professional preferred.

• Audit Skills: Demonstrated ability to perform internal audits and support external inspections.

• Project Management: Strong project management skills with the ability to drive root cause identification

and corrective actions.

• Communication: Excellent verbal and written communication skills, including proficiency in data

compilation and technical writing.

• Interpersonal: Strong interpersonal skills with the ability to work effectively within cross-functional

teams.

• Efficiency: Exceptional time management and organizational skills; able to multi-task and meet deadlines

in a fast-paced environment.

• Autonomy: Ability to work independently while remaining flexible to changing requirements.

• Business Acumen: Ability to align department achievements with overall organizational success.

• Technical Tools: Working knowledge of Microsoft Office applications and eQMS systems.

Preferred “Plus” Skills:

• Experience using Arena (eQMS).

• Experience with both IVD and CLIA quality regulations.

• Quality Certification(s)

Why Helio Genomics?

You’ll work in a collaborative environment and know your daily work will have a direct positive impact.

As an AI-driven healthcare company, we focus on detecting cancer early and enabling widespread adoption of convenient and affordable testing. By transforming the paradigm of screening, we can find cancer early—when it is most treatable—so everyone can have the best chance to beat it.

Helio Genomics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. We are committed to providing reasonable accommodation for individuals with disabilities.

Ready to apply

Reply via LinkedIn or send your resume to careers@heliogenomics.com.