Quality Engineer I

Nova Biomedical is hiring a Quality Engineer I on-site (hybrid) in our Waltham, MA facility. 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.

More specific responsibilities will include :

• 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.

Qualifications / Skills and Competencies :

• Certifications are not required but Certified Quality Auditor and / or Certified Quality Engineer is a plus.
• 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.

Education / Experience :

• 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.

At Nova Biomedical, we practice our core values of mutual respect, honesty, and integrity throughout the company. With a strong sense of family in the workplace, we are proud that one third of all our employees have been with us for over 10 years.

Highlights of benefits offered to Nova Biomedical employees include Blue Cross Blue Shield medical plan, tuition reimbursement, matching 401K, company subsidized cafeteria and an innovative scholarship program for children of employees.