Senior Quality Engineer

About the role

Nova Biomedical is a leading provider of advanced instruments and diagnostics, trusted globally for its innovative solutions in biopharmaceutical and clinical markets. This role plays a crucial part in ensuring the quality and compliance of these products through comprehensive quality engineering support.

Responsibilities

• Provide expertise and general oversight for the management and improvement of Nova Biomedical’s Quality Systems.
• Develop plans to resolve quality issues and communicate solutions effectively to leadership.
• Mentor quality engineers and make risk-based decisions.
• Prepare and review Engineering Change Orders (ECO) and Manufacturing Variances (MV).
• 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).
• Format, manage, and maintain Quality Control Plans and PFMEAs for new products.
• Analyze data and generate reports to identify trends and effective conclusions.
• Generate and review Validation Protocols and Reports (IQ, OQ, PQ).
• Ensure validation activities align with Nova Biomedical’s procedures.
• Maintain and oversee the Validation File and Log (Microsoft Excel), and the Validated Spreadsheet Log (Excel).
• Identify and implement problem-solving activities to determine root cause and corrective action.
• Contribute to the information gathering for the QMS management review process.
• Aid in improving Quality Systems and increasing compliance with regulations.
• Proactively identify quality system gaps and develop solutions to close them.

Requirements

• Bachelor's degree or higher in Engineering or the technical sciences.
• 7+ 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).
• 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 teams and understands task requirements.
• 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.