Quality Engineer II (Rockville, MD)

We understand that the world we want tomorrow starts with how we do business today, and that’s why we’re inspired to make A Better World for Pets. Antech is comprised of a diverse team of individuals who are committed to each other’s growth and development. Our culture is centered on our guiding philosophy, The Five Principles: Quality, Responsibility, Mutuality, Efficiency and Freedom. Today Antech is driving the future of pet health as part of Mars Science & Diagnostics, a family-owned company focused on veterinary care.

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We are seeking a detail-oriented and proactive Quality Engineer with experience in veterinary biotechnology to join our growing team. In this role, you will ensure all biotech products, ranging from vaccines to diagnostic tools, meet internal quality standards and comply with veterinary industry regulations. You will work cross-functionally to support product development, manufacturing, and compliance throughout the product lifecycle.

Essential Duties and Responsibilities

• Provide quality engineering support to manufacturing operations, including batch record review, deviation management, and in-process control monitoring.

• Assist in resolving quality issues on the production floor by collaborating with manufacturing, quality control, and engineering teams.

• Implement, and maintain quality systems in compliance with standard requirements and regulations (e.g., USDA APHIS, FDA CVM, ISO).

• Support validation and qualification of manufacturing equipment, utilities, and processes (IQ/OQ/PQ).

• Manage Nonconforming Material Reports (NCMRs), including investigation, segregation, documentation, and disposition of nonconforming products, and leading the Material Review Board.

• Lead and participate in root cause investigations and implement corrective and preventive actions (CAPA) related to manufacturing deviations and product issues.

• Collaborate with Operations, R&D and regulatory teams during the development and scale-up of new products.

• Analyze trends in manufacturing quality data to identify opportunities for continuous improvement and risk reduction.

• Support lot release testing, stability studies, and regulatory compliance activities.

• Conduct and support internal and external audits, including USDA CVB and FDA CVM inspections.

• Maintain and improve quality system documentation, such as batch records, part specifications, manufacturing travelers, etc.

• Ensure supplier-provided materials meet quality standards and support incoming inspections.

• Provide training on GMP, GLP, and manufacturing-related quality practices.

Education and Experience

• Bachelor's degree in biotechnology, Biomedical Engineering, Biology, or related field.

• A minimum of 4-7+ years of quality assurance experience, preferably in a regulated industry or equivalent combination of education and experience.

• Familiarity with GMP, GLP, QSR, and ISO 9001/13485 standards.

• Experience managing nonconforming materials, investigations, and dispositions.

• Proficiency in quality tools such as CAPA, FMEA, Root Cause Analysis, and 8D.

• Solid documentation, analytical, and communication skills.

Knowledge, Skills and Abilities

• Experience supporting biologics manufacturing in a USDA-licensed facility.

• Knowledge of aseptic manufacturing and cleanroom compliance requirements.

• Certified Quality Engineer (CQE) or Six Sigma certification.

• Experience supporting regulatory inspections (USDA CVB, FDA CVM).

• Knowledge of veterinary biologic regulations (e.g., USDA Center for Veterinary Biologics).

Travel

Will there be notable travel in this position? No

Working Conditions

The associate is regularly required to apply manual dexterity, including hand/wrist flexibility, for computer keyboarding.  The associate frequently is required to sit for extended periods of time, stand, walk, and reach with hands and arms.  The associate is frequently required to hear and speak in order to use the telephone, make presentations and communicate with people in an office environment.  The associate is occasionally required to sit and stoop, bend, kneel, or crouch.

About Antech

Antech is a leader in veterinary diagnostics, driven by our passion for innovation that delivers better animal health outcomes. Our products and services span 90+ reference laboratories around the globe; in-house diagnostic laboratory instruments and consumables, including rapid assay diagnostic products and digital cytology services; local and cloud-based data services; practice information management software and related software and support; veterinary imaging and technology; veterinary professional education and training; and board-certified specialist support services.

Benefits

Antech offers an industry competitive benefits package and continues to invest in and evolve benefits programs that meet the health, wellness and financial needs of our associates.

Benefits eligiblity is based on employment status.

• Paid Time Off & Holidays

• Medical, Dental, Vision (Multiple Plans Available)

• Basic Life (Company Paid) & Supplemental Life

• Short and Long Term Disability (Company Paid)

• Flexible Spending Accounts/Health Savings Accounts

• Paid Parental Leave

• 401(k) with company match

• Tuition/Continuing Education Reimbursement

• Life Assistance Program

• Pet Care Discounts

Commitment to Equal Employer Opportunities

We are proud to be an Equal Opportunity Employer - Veterans / Disabled. For a complete EEO statement, please see our Career page at Antech Careers.

Note to Search Firms/Agencies

Antech Diagnostics, Inc. and its subsidiaries and affiliates (Antech) do not compensate search firms for unsolicited assistance unless they have a written search agreement with Antech and the requisition is position-specific. Any resumes, curriculum vitae, and other unsolicited assistance from search firms that do not have a written search agreement or position-specific requisition submitted to any Associate of Antech will be deemed the sole property of Antech and no fee will be paid in the event the candidate is hired by Antech.