Quality Engineer II

Nova Biomedical: One Global Brand. One Vision. Together under one name.

Advanced Instruments and Nova Biomedical are now united under one brand, Nova Biomedical , marking a major milestone in our journey to deliver greater value to our customers. By combining our strengths, we're accelerating innovation, supporting critical workflows, and delivering world-class service across the biopharmaceutical and clinical markets.

About the company

At Nova Biomedical, we're not just building instruments, we're powering breakthroughs that improve lives. Our smart, science-driven solutions are trusted in over 100 countries to speed drug development and enhance patient care.

Our integration brings together more than 70 years of scientific excellence with Nova's cutting-edge innovation, forming a powerhouse of precision, purpose, and possibility. With FDA-registered, ISO-certified manufacturing, more than 125 FDA approvals, and industry-trusted diagnostics, we're setting new standards in quality and reliability. Nova Biomedical is proud to be a global leader in osmolality testing and biotechnology and in vitro diagnostic (IVD) instrumentation, dedicated to advancing patient care and scientific discovery with a legacy that continues to shape the future of life sciences.

With headquarters in Norwood and Waltham, Massachusetts, and a global team of nearly 2,000 employees, we're building a collaborative, empowered culture grounded in shared values: Customer Centricity, Ingenuity, Ownership & Accountability, Collaboration, and Integrity .

Working at Nova Biomedical means joining a mission-driven organization where your contributions matter. Whether you're in engineering, science, manufacturing, or support, you'll be part of a team that values innovation, invests in your growth, and is committed to making a real-world impact on global health.

Explore what's next with us at novabiomedical.com or aicompanies.com

About the role

This role supports Quality Assurance activities within the corporate Quality Management System (QMS), providing expertise and general oversight for the management and improvement of design and development, validations, quality planning, internal auditing, investigations, process controls, change management, quality records, and corrective and preventive actions. Responsibilities include conducting inspections of parts and products at multiple production stages to ensure compliance with approved procedures and ISO 17025 and ISO 17034 standards. The position gathers and analyzes inspection metrics, assists with internal investigations and root cause analyses for customer complaints, coordinates with vendors regarding defective materials, and other duties as assigned.

If you're passionate about engineering and want to be part of a team that is shaping the future of life sciences, we'd love to hear from you, apply today!

What you'll do

• Conduct inspections of parts and products, including instrumentation and test kits, at multiple production stages to confirm adherence to approved procedures and ISO 17025 and ISO 17034 requirements. Review "QC Required" move tickets to determine inspections requirements and plans based on the ERP system, object notes, or relevant documentation such as PPS.
• Gather and monitor inspection metrics, providing recommendations for modifications, additions, or reductions to inspection requirements as appropriate.
• Perform and support internal investigations related to customer complaints and internal deficiencies. Participate in root cause analysis and corrective and preventive action (CAPA) initiatives to ensure effective resolution of issues.
• Coordinate with the Purchasing department regarding vendor Return Material Authorizations (RMAs) for nonconforming materials and provide technical support to suppliers as needed.
• Develop and revise Standard Operating Procedures (SOPs) and prepare and review Engineering Change Orders (ECOs) to ensure accuracy and compliance with regulatory requirements.
• Draft and review Validation Protocols and Reports (IQ, OQ, PQ) to confirm adequacy, thoroughness, and compliance with Quality System requirements.
• Assist with the preparation for and participation in both internal and external audits, ensuring organizational readiness and compliance.
• Compile, present, review, and analyze quality data in collaboration with subject matter experts to identify trends and formulate meaningful conclusions.
• Other duties as assigned.

What we are looking for in you

• 2-4 years of quality engineering experience in the biotechnology field, or equivalent
• Knowledge of ISO 17025, ISO 17034, ISO 9001, and cGMP
• Experience in quality inspection, manufacturing, or related technical field preferred
• Ability to read and interpret engineering drawings and specifications
• Ability to understand sampling plans to determine inspection quality requirements
• Familiarity with measurement tools such as calipers, micrometers, and gauges
• Knowledge of quality control procedures, sampling plans, and documentation practices
• Advanced computer knowledge and proficiency with Microsoft Office tools
• Advanced math skills and sound understanding of statistical analysis; experience with statistical software (e.g., Minitab) is a plus
• Strong attention to detail, organizational skills, and ability to follow documented processes
• BS degree in Engineering, the sciences, or other technical discipline

Physical Requirements for this role include:

• Mix of office, production, and warehouse floor settings
• Requires standing, walking, and sitting for long periods of time.
• Able to safely lift up to 50 lbs and move freight with a pallet jack up to 500 lbs.

Why work for Nova Biomedical

• Flexible Medical, Dental, & Vision Coverage
• Competitive 401k company match
• Bonus Program, Generous PTO and paid holidays
• Generous Tuition reimbursement
• Hybrid and flexible work arrangements
• Professional development, engagement and events
• Company marketplace for lunch and snacks in our Norwood, MA, Billerica, MA and Westbrook, ME offices
• Company subsidized cafeteria in our Waltham, MA office

Work Location: On-site in our Westbrook office

Targeted Salary Range: $85,000 - $95,000/year

Nova Biomedical believes in transparency and integrity throughout all we do, including compensation. The provided salary range for this role represents the expected base salary or hourly rate for this opening. Actual compensation will be commensurate with the candidate's experience and may vary based on individual factors such as location, skills, and education.


EEO Statement:

Nova Biomedical takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As a part of our commitment to a diverse and inclusive workforce, Nova Biomedical will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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