Quality Assurance Laboratory Technician II

Epredia; Kalamazoo (MI); On-site; USD 45,000 - 65,000; Full time

Job summary

Epredia is seeking a Quality Assurance Lab Technician II in Kalamazoo, MI, onsite, 7:00AM–3:30PM. You will perform quality control testing on raw materials, in-process materials, and finished goods to ensure ISO 13485 compliance before release.

You’ll also collaborate with R&D to test new materials and optimize formulations. The role requires a strong histology background, experience with staining, microtomy, embedding, and documentation according to GDP/SOP/WINs.

Qualifications

• Associate or Bachelor’s degree in Histotechnology, Medical Laboratory Science, Biology, or a related field is preferred.
• HT (ASCP) or HTL (ASCP) certification is highly preferred but not required with equivalent industry experience.
• 2+ years of experience in a clinical histology lab or a regulated manufacturing quality control environment (ISO 13485, FDA21 CFR Part 820, or GMP).
• Strong proficiency in manual staining, microtomy (cutting), and embedding. Experience evaluating stain quality, color intensity, and tissue morphology under a microscope.
• Familiarity with a wide range of histological reagents, fixatives, and solvents.

Responsibilities

• Test raw materials, in-process bulk chemical formulations, and finished products against strict release specifications.
• Perform manual staining techniques exactly as prescribed by Instructions for Use (IFU) documents to verify product efficacy and visual quality.
• Utilize standard histology techniques (grossing, embedding, microtomy, and slide preparation) to test the functionality of manufacturing reagents and waxes.
• Record all test results accurately in compliance with GDP, SOPs, and WINs.
• Work alongside R&D scientists to evaluate and tweak chemical formulations for improved performance or cost-efficiency.
• Test and validate new or alternative raw materials to ensure they meet performance and regulatory standards.
• Maintain strict adherence to medical device QMS requirements and participate in audits as needed.
• Coordinate with manufacturing to minimize bottlenecks in a high-throughput environment.

Skills

Manual staining

Microtomy

Embedding

GDP/SOP/WINs documentation

Education

Associate or Bachelor’s degree in Histotechnology/Medical Laboratory Science/Biology/Chemistry

HT (ASCP) or HTL (ASCP) certification (preferred)

Tools

Histology equipment

Job description

Make a Meaningful Impact

Ready to join a team where your work makes a daily difference in healthcare?

Epredia is a global leader in precision cancer diagnostics solutions. In fact, every second, our products are used 48 times in labs and medical facilities around the world.

We are a proud member of PHC Group, a global collection of companies committed to delivering precision technology for the future of healthcare, from specialized medical equipment to health IT systems to research tools.

Title: Quality Assurance Lab Technician II

Location: Kalamazoo, MI

Work Arrangement: Onsite - 7:00AM - 3:30PM M-F

Employment Type: Full-Time

The Opportunity

We are seeking a skilled and detail-oriented Histologist to join our fast-paced Quality Lab team. In this role, you will perform critical quality control testing on raw materials, bulk formulations, and finished goods to ensure compliance with ISO 13485 standards before products are released to consumers. Beyond routine quality control, you will collaborate directly with our Research and Development (R&D) team to test new raw materials and help optimize product formulas.

How You’ll Make An Impact

• Test raw materials, in-process bulk chemical formulations, and finished products against strict release specifications.
• Perform manual staining techniques exactly as prescribed by Instructions for Use (IFU) documents to verify product efficacy and visual quality.
• Utilize standard histology techniques (grossing, embedding, microtomy, and slide preparation) to test the functionality of our manufacturing reagents and waxes.
• Record all test results accurately in compliance with Good Documentation Practices (GDP), Standard Operating Procedures (SOPs), and Work Instructions (WINs).
• Work alongside R&D scientists to evaluate and tweak chemical formulations for improved performance or cost-efficiency.
• Test and validate new or alternative raw materials to ensure they meet performance and regulatory standards.
• Maintain strict adherence to medical device quality management system (QMS) requirements and participate in internal/external audits as needed.
• Coordinate closely with the manufacturing team in a high-throughput environment to minimize production bottlenecks and support timely product releases.

Bring Your Expertise

• Associate or Bachelor’s degree in Histotechnology, Medical Laboratory Science, Biology, Chemistry, or a related scientific field is preferred.
• HT (ASCP) or HTL (ASCP) certification is highly preferred but not required with equivalent industry experience.
• 2+ years of experience in a clinical histology lab or a regulated manufacturing quality control environment (ISO 13485, FDA21 CFR Part 820, or GMP).
• Strong proficiency in manual staining, microtomy (cutting), and embedding. Experience evaluating stain quality, color intensity, and tissue morphology under a microscope.
• Familiarity with a wide range of histological reagents, fixatives, and solvents.

Ready to Make an Impact?

If this opportunity aligns with your skills and career goals, we’d love to hear from you.

Building an Inclusive Culture

We are a company that brings the best people together and leverages their varying backgrounds, ideas, and points of view to invent on behalf of all customers. We are committed to equal employment opportunity for all individuals, without regard to race, color, national origin, ancestry, sex, age, religion, physical or mental disability, medical condition, veteran status, marital status, pregnancy, sexual orientation, gender identity, genetic information, or any other protected classes which may exist under applicable federal, state, or local law.