Quality Assurance Laboratory Technician II

1101 Richard-Allan Scientific LLC; Kalamazoo (MI); On-site; USD 52,000 - 70,000; Full time

Job summary

Ascensia Diabetes Care is seeking a skilled Histology Lab Technician II to join our Quality Lab in Kalamazoo, MI. This onsite role supports release testing of materials and finished products with strict adherence to ISO 13485 and GDP standards.

The ideal candidate has a histology background, ASCP HT/HTL preferred, 2+ years in a regulated lab, and strong staining, embedding, and microtomy skills to ensure product quality and regulatory compliance.

Qualifications

• Associate or Bachelor’s degree in Histotechnology, Medical Laboratory Science, Biology, or Chemistry.
• HT (ASCP) or HTL (ASCP) certification preferred but not required with equivalent industry experience.
• 2+ years of experience in a clinical histology lab or regulated manufacturing quality control environment (ISO 13485, FDA21 CFR Part 820, or GMP).
• Strong proficiency in manual staining, microtomy, 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 formulations, and finished products against release specifications.
• Perform manual staining techniques exactly as prescribed by Instructions for Use to verify product efficacy and visual quality.
• Utilize standard histology techniques (grossing, embedding, microtomy, and slide preparation) to test reagents and waxes.
• Record all test results accurately in GDP, SOPs, and WINs.
• Collaborate with R&D scientists to evaluate and tweak formulations for performance or cost-efficiency.
• Test and validate new or alternative raw materials to ensure they meet standards.
• Maintain adherence to QMS requirements and participate in audits as needed.
• Coordinate with manufacturing to minimize bottlenecks and support timely releases.

Skills

Manual staining

Microtomy

Embedding

Histology QC

Education

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

Job description

Make a Meaningful Impact Ascensia Diabetes Care is a global company entirely dedicated to improving the health and lives of people with diabetes. Our world-renowned CONTOUR™ portfolio of blood glucose monitoring systems combines advanced technology with user-friendly functionality to help people manage their condition. 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.

#LI-HH1 #DE-EPREDIA

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.