Quality Engineer I

Nova Biomedical; Norwood (MA); Híbrido; USD 85.000 - 105.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive 401k match

Bonus Program

Generous PTO and paid holidays

Hybrid and flexible work arrangements

Descripción de la vacante

Nova Biomedical seeks a Quality Assurance professional to uphold and improve our Quality System in support of ISO, FDA QSR, and MDSAP compliance. The role provides front and backroom support during external regulatory audits and inspections, and leads efforts in internal auditing and validation reporting.

You will drive quality planning for new products, investigate CAPAs, review nonconforming materials, and help prepare SOPs and ECOs.

Formación

• BS degree in engineering, the sciences, or another technical discipline.
• 1-2 years of quality engineering experience in the medical device/biotech fields, or equivalent.

Responsabilidades

• Maintain and improve the Quality System to ensure ISO, QSR, and MDSAP compliance.
• Support external regulatory audits and factory inspections (FDA, TUV, Partners, Customers).
• Participate in Nova's Internal Quality Auditing program.
• Review Validation Protocols and Reports (IQ, OQ, PQ) for quality and compliance.

Conocimientos

Quality Assurance

Regulatory knowledge

Statistical analysis

Technical reading

Communication

Educación

BS degree in engineering or science

Herramientas

Minitab

Microsoft Office

MS Excel

Descripción del empleo

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.

Job Summary

This role will support Quality Assurance activities within the corporate Quality Management System (QMS). Responsibilities include 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, corrective and preventive activities, data management, employee training, and other duties as assigned.

Responsibilities

• Maintain and improve the Quality System to ensure compliance with ISO standards, QSR Regulations, and MDSAP.
• Provide front and backroom support during external regulatory body audits and factory inspections such as FDA, TUV, Partners, and Customers.
• Participate in Nova's Internal Quality Auditing program.
• Generate and review Validation Protocols and Reports (IQ, OQ, PQ) for adequacy, completeness, and compliance with Quality Systems requirements.
• Drive Quality Planning activities in support of new product launches and Quality System improvements.
• Participate in problem-solving activities to determine root cause and effective corrective action and other CAPA activities.
• Perform and assist with internal investigations (NIRs) for customer complaints and/or deficiencies identified internally.
• Review and approve nonconforming material reports, artwork proofs, and First Article Inspections.
• Create and update Standard Operating Procedures (SOPs).
• Prepare and review Engineering Change Orders (ECO) and Manufacturing Variances (MV).
• Participate in the identification, planning, implementation, and monitoring of continuous improvement projects to reduce defects and improve overall product quality.
• Manage and maintain quality data including design and validation of new or existing databases, queries, and reports.
• Prepare, present, review, and analyze quality data with SMEs to identify trends and draw effective conclusions.
• Provide general oversight and training on Quality procedures and practices.

Skills & Competencies

• Excellent oral and written communication.
• Read and interpret technical documents.
• Exercise judgement in selecting methods and techniques for obtaining results and problem solving.
• Advanced math skills and sound understanding of statistical analysis; previous experience with Statistical software (e.g., Minitab) is a plus.
• Advanced computer knowledge and proficiency with Microsoft Office tools.
• Basic knowledge of FDA QSR, MDSAP, IVDD/IVDR, and ISO 13485.

Experience Requirements

BS degree in engineering, the sciences, or another technical discipline.

1-2 years of quality engineering experience in the medical device and/or biotechnology fields, or equivalent.

Physical Requirements and Working Conditions

Comfort with working at a computer for extended periods.

Capacity to lift and carry up to [25-50] pounds as required

Able to communicate effectively via phone, video, and written communication.

Occasional need to move about the office to access meetings or resources.

• Ability to work at a desk

Why Work for Nova Biomedical

Competitive 401k company match

Bonus Program, Generous PTO and paid holidays

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

Targeted Salary Range

$85,000 - $105,000/yr

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.

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.

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.