Senior Quality Engineer

American Society for Quality; Billerica (MA); Hybrid; USD 125,000 - 135,000; Full time

Benefits offered by this job

Flexible medical, dental, & vision

401k match

Tuition reimbursement

Hybrid work arrangements

Job summary

The Senior Quality Engineer at Nova Biomedical will provide Quality Engineering support across design transfer, inspection, production, field returns and data monitoring, driving quality practices and process improvements.

You'll lead root cause investigations, support quality systems, and collaborate with multi-disciplinary teams to ensure ISO13485, FDA, and regulatory compliance while delivering robust data insights through PFMEAs, Minitab and Power BI.

Qualifications

• 8+ years in Medical Device/IVD quality engineering.
• Knowledge of ISO13485, ISO14971, MDSAP and FDA 21 CFR Part 820.
• Experience with PFMEAs, risk analysis and validation plans.
• Experience validating IQ/OQ/PQ and data trending.

Responsibilities

• Oversee Quality Systems, including audits, document control, change management.
• Prepare ECOs and manufacturing variances.
• Lead Product Line Quality Committees.
• Develop and validate quality reports and data queries.
• Perform DHR reviews and support CAPA activities.

Skills

Quality Engineering

Data analysis

Root cause analysis

Statistical methods

Communication skills

Problem solving

Education

Bachelor's degree in Engineering

Tools

Minitab

MasterControl

Power BI

MS Access

Job description

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

The Senior Quality Engineer will provide Quality Engineering support to ensure that quality practices are effectively implemented and maintained across design transfer, incoming inspection, production, field returns, and data monitoring. This role will also support Engineering by offering troubleshooting guidance and will lead process improvement initiatives to enhance yield and overall product quality.

Responsibilities

• Provide expertise and general oversight for the management of Nova Biomedical's Quality Systems, including quality planning, quality control planning, internal auditing, inspection procedures, document controls, change management, process controls, quality records, corrective and preventive activities, validations, and data management.
• Prepare and review Engineering Change Orders (ECO) and Manufacturing Variances (MV) for operating procedures and operating instructions.
• Participate in and/or lead Product Line Quality Committees (PLQC) as appropriate.
• Format, manage and maintain Quality Control Plans and PFMEAs for new and existing products to ensure that Quality Requirements are in place when new products are introduced into Manufacturing and that any significant process updates are properly reflected.
• Support Quality Plan activities in support of company projects.
• Design and validate queries and reports for data from Production, Non-Conforming Materials, Field Return Investigation, and Corrective & Preventive Actions on the Database.
• Analyze data and generate reports to identify trends and to draw effective conclusions.
• Generate and review Validation Protocols and Reports (IQ, OQ, PQ) for adequacy, completeness, and compliance with Quality Systems requirements.
• Ensure that validation activities are appropriate to their needs and in alignment with Nova Biomedical's procedures.
• Identify and implement problem-solving activities to determine root cause and effective corrective action.
• Assist management with improving Quality Systems and increasing plant-wide compliance with appropriate regulations.
• Perform DHR reviews to support complaint responses.
• Validate and maintain testing spreadsheets.

Experience Requirements

• Bachelor's degree or higher in Engineering or the technical sciences, or equivalent experience.
• 8 plus years Medical Device/IVD Experience as a Quality Engineer within an FDA regulated reagents, medical device, or IVD manufacturing company.
• Strong working knowledge of ISO13485, ISO14971, MDSAP, and FDA Regulations (21CFR Part820).
• Thorough understanding of data trending techniques, and previous experience developing product and process trends and reporting to senior management.
• Experience performing validations (IQ, OQ, PQ) of manufacturing/quality equipment, processes, and/or test methods is a plus.
• Experience performing and reviewing PFMEAs, Risk Analysis, and Validation Plans.
• Knowledge of inspection methods, sampling plans, statistical analysis, and Statistical Process Control (SPC).
• Experience with performing internal audits.
• Excellent oral and written communication skills, prioritization, and multi-tasking skills.
• Knowledge of manufacturing processes and their associated risk to product.
• Detail-oriented, able to read and interpret technical documents.
• Work well with multi-disciplined team and understand task requirements.
• Ability to exercise judgement in selecting methods and techniques for obtaining results.
• Computer literacy including MS Word, MS Excel MS Access.
• Statistical Software experience, i.e. Minitab.Previous experience working with Master Control and/or Power BI a plus.
• Auditing experience is a plus. ASQ Certification as Medical Device Auditor is a plus.
• ASQ Certification as Quality Engineer is preferred.

Physical Requirements and Working Conditions

• Ability to stand, walk, and move for extended periods.
• Ability to lift and carry up to [25–50] pounds as required.
• Ability to perform repetitive physical tasks.
• Ability to bend, reach, stoop, or climb as needed.
• Ability to work in varying environmental conditions (e.g., noise, temperature, equipment).
• Ability to operate tools, machinery, or technical equipment.
• Use of appropriate personal protective equipment (PPE) required.

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

Hybrid work schedule on-site in Lexington Road, Billerica, [4-5] days/week on-site

Targeted Salary Range

$125,000 - $135,000/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.

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.

Explore what’s next with us at

novabiomedical.com

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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