Process Quality Engineer

Our client is seeking a Process Quality Engineer to support manufacturing, quality, and regulatory activities within a regulated In Vitro Diagnostics (IVD) manufacturing environment. This individual will play a key role in improving manufacturing processes, maintaining validation programs, supporting quality systems, and ensuring compliance with FDA and international regulatory requirements. The position works closely with Manufacturing, R&D, Quality, Regulatory, and Supply Chain to drive operational excellence and continuous improvement.

Qualifications of the Process Quality Engineer:

• Bachelor's degree in Engineering, Life Sciences, Chemistry, or a related technical discipline.
• 4+ years of experience in Process Engineering, Quality Engineering, Quality Assurance, or Regulatory Affairs within an IVD or regulated medical device manufacturing environment.
• Strong working knowledge of FDA QMSR (21 CFR Part 820), ISO 13485, and European IVD regulations (IVDR).
• Experience with process validation, equipment qualification, statistical process control, CAPA, root cause analysis, and risk management.
• Experience with Design of Experiments (DOE) is preferred.
• Strong technical writing, analytical, and problem-solving skills.
• Excellent communication and cross-functional collaboration skills.
• Experience supporting reagent or diagnostic kit manufacturing is highly preferred.

Responsibilities of the Process Quality Engineer:

• Design, develop, and optimize manufacturing processes to improve quality, efficiency, and throughput.
• Develop and maintain process documentation, flow diagrams, control plans, and manufacturing procedures.
• Support new product introduction and transfer from development into manufacturing.
• Lead Lean Manufacturing and Six Sigma process improvement initiatives.
• Analyze manufacturing metrics such as yield, scrap, Cp/Cpk, and process capability to identify improvement opportunities.
• Monitor manufacturing operations to ensure compliance with quality standards and regulatory requirements.
• Develop statistical sampling plans and process controls.
• Lead process changes through established change control procedures.
• Maintain and execute site validation activities.
• Author, execute, and review validation protocols and reports for equipment, processes, software, facilities, utilities, analytical methods, and related systems.
• Maintain traceability documentation and validation records.
• Perform periodic validation reviews and revalidation activities.
• Ensure validation documentation complies with regulatory and quality system requirements.
• Lead investigations involving CAPAs, nonconformances, deviations, complaints, out-of-specification (OOS), and related quality events.
• Develop and maintain Quality Management System (QMS) procedures and documentation.
• Participate in risk management activities including FMEA and related methodologies.
• Support FDA, ISO, customer, certification body, and internal audits.
• Assist with regulatory documentation and technical file maintenance.
• Support supplier quality activities, including supplier qualification and ongoing monitoring.
• Participate in post-market quality activities, adverse event reporting, and complaint investigations.

Occupational Code 17-2199 – Engineers, All Other