Senior Quality Engineer

Nova Biomedical • Norwood, MA

6d • Hybrid

About The Position

The Senior Quality Engineer provides Quality Engineering support to ensure quality practices are implemented and maintained across design transfer, inspection, production, and data monitoring. The role leads quality initiatives and projects, supports process and equipment qualification, and collaborates with R&D and Manufacturing Engineering to resolve issues and maintain compliance with established procedures. It also ensures Quality Systems are integrated into operational activities and represents the site’s quality management system by communicating with leadership and influencing continuous improvement.

The position oversees and improves Nova Biomedical’s Quality Systems, supports quality planning and control, audits, inspection procedures, document controls, change and process management, quality records, corrective and preventive actions, validations, and data management. It develops solutions to quality issues, mentors quality engineers, contributes to management review, and helps improve plant-wide compliance. The role also supports product introductions, validation activities, audits, data analysis, and ongoing identification and closure of quality system gaps.

The position follows a hybrid schedule, with four days per week on-site in Norwood, Massachusetts. The targeted base salary range is $110,000–$130,000 per year.

Requirements

• Bachelor’s degree or higher in Engineering or the technical sciences.
• At least 7 years of Medical Device/IVD experience as a Quality Engineer, or at least 4 years as a Senior Quality Engineer within an FDA-regulated reagents, medical device, or IVD manufacturing company.
• Knowledge of regulations and standards affecting IVDs and medical devices, including ISO 9001, ISO 13485, ISO 14971, and IVDR, and the ability to interpret and apply them appropriately.
• Experience in an FDA-regulated environment.
• Excellent oral and written communication, prioritization, and multitasking skills.
• Detail-oriented, with the ability to read and interpret technical documents.
• Ability to work with multidisciplinary teams and understand task requirements.
• Ability to exercise judgment in selecting methods and techniques for obtaining results.
• Computer literacy, including MS Word, MS Excel, and MS Access.
• Able to stand or sit for extended periods.
• Manual dexterity to handle laboratory equipment and instrumentation.
• Capacity to lift and carry up to 25 pounds.
• Comfort performing repetitive tasks.
• Willingness to work in a laboratory environment with exposure to chemicals or biological materials.
• Ability to use required personal protective equipment (PPE).
• Ability to bend, reach, or move within the laboratory environment occasionally.

Nice To Haves

• Previous experience working with MasterControl and/or Power BI.
• Auditing experience and certification.

Responsibilities

• Provide expertise and general oversight for the management and improvement of 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.
• Develop plans to resolve quality issues and use communication and analytical skills to build support for changes.
• Communicate with leadership about the advantages and disadvantages of proposed changes and present solutions that meet business and quality/compliance needs.
• Mentor quality engineers.
• Make risk-based decisions.
• Prepare and review Engineering Change Orders (ECOs) and Manufacturing Variances (MVs) for operating procedures and instructions.
• Design and validate database queries and reports for Production, Non-Conforming Materials, and Corrective and Preventive Actions data.
• Participate in or lead Product Line Quality Committees (PLQCs), as appropriate.
• Format, manage, and maintain Quality Control Plans and PFMEAs for new products so quality requirements are in place when products enter Manufacturing.
• Review and analyze specifications relating to acceptance activities.
• Support Quality Plan activities for company projects.
• Analyze data and generate reports to identify trends and draw conclusions.
• Generate and review IQ, OQ, and PQ Validation Protocols and Reports for adequacy, completeness, and compliance with Quality Systems requirements.
• Participate in external audits and, when appropriate, interact directly with auditors to address concerns and answer questions.
• Ensure validation activities are appropriate to their needs and align with Nova Biomedical procedures.
• Maintain and oversee the Nova Biomedical Validation File and Log and the Validated Spreadsheet Log and File, maintained in Excel.
• Identify and implement problem-solving activities to determine root causes and effective corrective actions.
• Contribute information to the Quality Management Review process.
• Assist management with improving Quality Systems and increasing plant-wide compliance with applicable regulations.
• Proactively identify Quality System gaps and develop solutions to close them, leveraging existing systems.

Benefits

• Flexible medical, dental, and vision coverage.
• Competitive 401(k) company match.
• Bonus program.
• Generous paid time off and paid holidays.
• Tuition reimbursement.
• Hybrid and flexible work arrangements.
• Professional development, engagement, and events.
• Company marketplace for lunch and snacks at the Norwood, Billerica, and Westbrook offices.
• Company-subsidized cafeteria at the Waltham office.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior