Quality Engineer I

Nova Biomedical • Norwood, MA

1d • $85,000 - $105,000 • Onsite

About The Position

This role supports Quality Assurance activities within Nova Biomedical’s corporate Quality Management System (QMS). It provides expertise and general oversight in 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, and employee training.

The Quality Engineer helps maintain compliance with ISO standards, QSR Regulations, and MDSAP; supports external regulatory audits and factory inspections; and contributes to internal audits, validation reviews, quality planning, investigations, continuous improvement, and quality data management. The position is on-site five days per week.

Requirements

• Bachelor’s 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.
• Excellent oral and written communication skills.
• Ability to read and interpret technical documents.
• Ability to exercise judgment in selecting methods and techniques for obtaining results and solving problems.
• Advanced math skills and a sound understanding of statistical analysis.
• Advanced computer knowledge and proficiency with Microsoft Office tools.
• Basic knowledge of FDA QSR, MDSAP, IVDD/IVDR, and ISO 13485.
• Comfort working at a computer for extended periods.
• Ability to lift and carry up to 25–50 pounds as required.
• Ability to communicate effectively by phone, video, and in writing.
• Ability to move about the office occasionally to access meetings or resources and to work at a desk.

Nice To Haves

• Previous experience with statistical software such as Minitab.

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, including those conducted by the FDA, TUV, partners, and customers.
• Participate in Nova’s Internal Quality Auditing program.
• Generate and review IQ, OQ, and PQ validation protocols and reports for adequacy, completeness, and compliance with Quality Systems requirements.
• Drive Quality Planning activities supporting new product launches and Quality System improvements.
• Participate in problem-solving activities to determine root causes and effective corrective actions, and support other CAPA activities.
• Perform and assist with internal investigations (NIRs) for customer complaints and internally identified deficiencies.
• 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 (ECOs) and Manufacturing Variances (MVs).
• Participate in identifying, planning, implementing, and monitoring continuous improvement projects to reduce defects and improve product quality.
• Manage and maintain quality data, including the design and validation of new or existing databases, queries, and reports.
• Prepare, present, review, and analyze quality data with subject matter experts to identify trends and draw conclusions.
• Provide general oversight and training on Quality procedures and practices.

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: Entry Level