Senior Quality Engineer

Nova Biomedical; Norwood (MA); Hybrid; USD 110,000 - 130,000; Full time

Benefits offered by this job

Flexible Medical, Dental, & Vision Coverage

401(k) company match

Bonus Program

Generous PTO and paid holidays

Tuition Reimbursement

Company subsidized cafeteria

Hybrid work arrangements

Job summary

Nova Biomedical, located in Norwood, MA, seeks a Senior Quality Engineer responsible for ensuring comprehensive quality practices across design transfer and production. This role requires leading quality initiatives, supporting equipment qualification, and resolving issues with R&D and Manufacturing Engineering.

The ideal candidate will have a Bachelor's degree in Engineering, 7+ years in a medical device environment, and strong knowledge of regulations such as ISO 9001 and ISO 13485. The position offers a hybrid work schedule and competitive benefits.

Qualifications

• 7+ years of experience as a Quality Engineer in a medical device/IVD company.
• Ability to interpret regulations and apply them appropriately.
• Experience in an FDA regulated environment.

Responsibilities

• Oversee and improve Nova Biomedical’s Quality Systems.
• Develop and communicate plans to resolve quality issues.
• Participate in external audits and interact with auditors.

Skills

Quality Systems Management

Regulations Knowledge (ISO 9001, ISO 13485)

Medical Device Experience

Excellent Communication Skills

Detail-oriented

Education

Bachelor’s degree in Engineering or Technical Sciences

Tools

MS Excel

Statistical Software (e.g. Minitab)

Master Control

Job description

Job Summary

The Senior Quality Engineer will be responsible for providing Quality Engineering support to ensure quality practices are implemented and maintained across design transfer, inspection, production, and data monitoring. This role leads quality initiatives and projects, supports process and equipment qualification, and ensures compliance with established procedures by collaborating with R&D and Manufacturing Engineering to resolve issues. Additionally, it ensures Quality Systems are integrated into all operational activities and represents the site’s quality management system by communicating and influencing leadership on continuous improvements.

Responsibilities

• Provide expertise and general oversight for the management and improvement 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.
• Develop plans to resolve quality issues and use communication and analytical skills to generate support for changes. Effectively communicate with leadership to weigh pros and cons of changes and present solutions that meet business and quality/compliance needs.
• Mentor quality engineers.
• Make risk‑based decisions confidently.
• Prepare and review Engineering Change Orders (ECO) and Manufacturing Variances (MV) for operating procedures and operating instructions.
• Design and validate queries and reports for data from Production, Non‑Conforming Materials and Corrective and Preventive Actions on the Database.
• Participate in and/or lead Product Line Quality Committees (PLQC) as appropriate.
• Format, manage and maintain Quality Control Plans and PFMEAs for new products to ensure that Quality Requirements are in place when new products are introduced into Manufacturing.
• Review and analyze specifications relating to acceptance activities.
• Support Quality Plan activities in support of company projects.
• 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.
• Participate in external audits and where appropriate interact directly with auditors to address concerns and answer queries.
• Ensure that validation activities are appropriate to their needs and in alignment with Nova Biomedical’s procedures.
• Maintain and oversee the Nova Biomedical Validation File and Log (a Microsoft Excel file) and the Nova Biomedical Validated Spreadsheet Log (Excel) and File.
• Identify and implement problem‑solving activities to determine root cause and effective corrective action.
• Quality Management Review: Contribute to the information gathering for the QMS management review process.
• Assist management with improving Quality Systems and increasing plant‑wide compliance with appropriate regulations.
• Proactively identify quality system gaps and develop solutions to close gaps, leveraging existing quality systems.

Experience Requirements

• Bachelor’s degree or higher in Engineering or the technical sciences.
• 7 plus years Medical Device/IVD Experience as a Quality Engineer, or 4+ 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 (ISO 9001, ISO 13485, & ISO 14971, IVDR) and the ability to interpret regulations and apply appropriately.
• Experience in FDA regulated environment.
• Excellent oral and written communication skills, prioritization, and multi‑tasking skills.
• Detail‑oriented, able to read and interpret technical documents.
• Works 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 is a plus.
• Auditing experience and certification is preferred.

Physical Requirements And Working Conditions

• Ability to work in an office, laboratory, and light manufacturing environment as needed.
• Ability to sit or stand for extended periods while reviewing documentation, participating in meetings, or supporting lab activities.
• Ability to lift, carry, or move equipment, test fixtures, or materials up to 25 lbs occasionally.
• Ability to perform hands‑on tasks such as inspecting components, handling small parts, or supporting test setups that may require fine motor skills.
• Ability to wear appropriate PPE (e.g., lab coat, gloves, safety glasses) when working in laboratory or production areas.
• Ability to move between different work areas, including R&D labs, production floors, and meeting spaces.
• Visual acuity sufficient to read engineering drawings, specifications, and test data, both on screens and on paper.
• Occasional travel (up to 10%) to suppliers, manufacturing partners, or other company sites may be required.

Why Work for Nova Biomedical

• Flexible Medical, Dental, & Vision Coverage
• Competitive 401(k) 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 Norwood, MA, 4 days/week on‑site.

Targeted Salary Range

$110,000 - $130,000/year.

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.