Senior Quality Engineer

About the role

The Senior Quality Engineer will provide Quality Engineering support to ensure that quality practices are effectively implemented and maintained across various stages of product lifecycle. This role supports Engineering by offering troubleshooting guidance and leading process improvement initiatives.

Responsibilities

• Provide expertise and general oversight for the management 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.
• Prepare and review Engineering Change Orders (ECO) and Manufacturing Variances (MV) for operating procedures and operating instructions.
• Participate in and/or lead Product Line Quality Committees (PLQC) as appropriate.
• Format, manage and maintain Quality Control Plans and PFMEAs for new and existing products.
• 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.
• Ensure that validation activities are appropriate to their needs and in alignment with Nova Biomedical’s procedures.
• Identify and implement problem-solving activities to determine root cause and effective corrective action.
• Aid management in improving Quality Systems and increasing plant-wide compliance with appropriate regulations.

Requirements

• Strong working knowledge of ISO13485, ISO14971, MDSAP, and FDA Regulations (21CFR Part820).
• Thorough understanding of data trending techniques, and previous experience developing product and process trends and reporting to senior management.
• Experience performing validations (IQ, OQ, PQ) of manufacturing/quality equipment, processes, and/or test methods.
• Experience performing and reviewing PFMEAs, Risk Analysis, and Validation Plans.
• Knowledge of inspection methods, sampling plans, statistical analysis, and Statistical Process Control (SPC).
• Experience performing internal audits.
• 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 a plus.
• Green Belt Six Sigma Certification is a plus.

Physical Requirements and Working Conditions

• Ability to stand, walk, and move for extended periods.
• Ability to lift and carry up to [25–50] pounds as required.
• Ability to perform repetitive physical tasks.
• Ability to bend, reach, stoop, or climb as needed.
• Ability to work in varying environmental conditions (e.g., noise, temperature, equipment).
• Ability to operate tools, machinery, or technical equipment.
• Use of appropriate personal protective equipment (PPE) required.

Pay

Targeted Salary Range: $125,000 - $135,000/year. Actual compensation will be commensurate with the candidate’s experience and may vary based on individual factors such as location, skills, and education.

Schedule

Hybrid work schedule on-site in Lexington Road, Billerica, [4-5] days/week on-site.