Quality Engineer II

Nova Biomedical Corporation • Westbrook, ME

4d • Onsite

About The Position

This role supports Quality Assurance activities within the corporate Quality Management System (QMS), 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, and corrective and preventive actions. Responsibilities include conducting inspections of parts and products at multiple production stages to ensure compliance with approved procedures and ISO 17025 and ISO 17034 standards. The position gathers and analyzes inspection metrics, assists with internal investigations and root cause analyses for customer complaints, coordinates with vendors regarding defective materials, and other duties as assigned. If you’re passionate about engineering and want to be part of a team that is shaping the future of life sciences, we’d love to hear from you, apply today!

Requirements

• 2–4 years of quality engineering experience in the biotechnology field, or equivalent
• Knowledge of ISO 17025, ISO 17034, ISO 9001, and cGMP
• Ability to read and interpret engineering drawings and specifications
• Ability to understand sampling plans to determine inspection quality requirements
• Familiarity with measurement tools such as calipers, micrometers, and gauges
• Knowledge of quality control procedures, sampling plans, and documentation practices
• Advanced computer knowledge and proficiency with Microsoft Office tools
• Advanced math skills and sound understanding of statistical analysis; experience with statistical software (e.g., Minitab) is a plus
• Strong attention to detail, organizational skills, and ability to follow documented processes
• BS degree in Engineering, the sciences, or other technical discipline

Nice To Haves

• Experience in quality inspection, manufacturing, or related technical field preferred

Responsibilities

• Conduct inspections of parts and products, including instrumentation and test kits, at multiple production stages to confirm adherence to approved procedures and ISO 17025 and ISO 17034 requirements.
• Review "QC Required" move tickets to determine inspections requirements and plans based on the ERP system, object notes, or relevant documentation such as PPS.
• Gather and monitor inspection metrics, providing recommendations for modifications, additions, or reductions to inspection requirements as appropriate.
• Perform and support internal investigations related to customer complaints and internal deficiencies.
• Participate in root cause analysis and corrective and preventive action (CAPA) initiatives to ensure effective resolution of issues.
• Coordinate with the Purchasing department regarding vendor Return Material Authorizations (RMAs) for nonconforming materials and provide technical support to suppliers as needed.
• Develop and revise Standard Operating Procedures (SOPs) and prepare and review Engineering Change Orders (ECOs) to ensure accuracy and compliance with regulatory requirements.
• Draft and review Validation Protocols and Reports (IQ, OQ, PQ) to confirm adequacy, thoroughness, and compliance with Quality System requirements.
• Assist with the preparation for and participation in both internal and external audits, ensuring organizational readiness and compliance.
• Compile, present, review, and analyze quality data in collaboration with subject matter experts to identify trends and formulate meaningful conclusions.
• Other duties as assigned.

Benefits

• 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

What This Job Offers

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