Senior Quality Engineer

Nova Biomedical: One Global Brand. One Vision. Together under one name. Advanced Instruments and Nova Biomedical are now united under one brand, Nova Biomedical, marking a major milestone in our journey to deliver greater value to our customers. By combining our strengths, we’re accelerating innovation, supporting critical workflows, and delivering world‑class service across the biopharmaceutical and clinical markets.

The Senior Quality Engineer will provide Quality Engineering support to ensure that quality practices are effectively implemented and maintained across design transfer, incoming inspection, production, field returns, and data monitoring. This role will also support Engineering by offering troubleshooting guidance and will lead process improvement initiatives to enhance yield and overall product quality.

• 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 to ensure that Quality Requirements are in place when new products are introduced into Manufacturing and that any significant process updates are properly reflected.
• Support Quality Plan activities in support of company projects.
• Design and validate queries and reports for data from Production, Non-Conforming Materials, Field Return Investigation, and Corrective & Preventive Actions on the Database.
• 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.
• Assist management with improving Quality Systems and increasing plant‑wide compliance with appropriate regulations.
• Perform DHR reviews to support complaint responses.
• Validate and maintain testing spreadsheets.

• Bachelor's degree or higher in Engineering or the technical sciences, or equivalent experience.
• 8 plus years Medical Device/IVD Experience as a Quality Engineer within an FDA regulated reagents, medical device, or IVD manufacturing company.
• Strong working knowledge of ISO
  13485, ISO
  14971, MDSAP, and FDA Regulations (21
  
  CFR Part
  820).
• 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 is a plus.
• Experience performing and reviewing PFMEAs, Risk Analysis, and Validation Plans.
• Knowledge of inspection methods, sampling plans, statistical analysis, and Statistical Process Control (SPC).
• Experience with performing internal audits.
• Excellent oral and written communication skills, prioritization, and multi‑tasking skills.
• Knowledge of manufacturing processes and their associated risk to product.
• Detail-oriented, able to read and interpret technical documents.
• Work 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.
• Auditing experience is a plus. ASQ Certification as Medical Device Auditor is a plus.
• ASQ Certification as Quality Engineer is preferred.

• Abili…