Technical Investigator

Technical Investigator

The Technical Investigator is responsible for leading and supporting technical investigations related to manufacturing deviations, nonconformances, customer complaints, process issues, and quality events within a medical device manufacturing environment. This role conducts thorough root cause analysis, evaluates production and quality data, documents investigation findings, and supports the development of effective corrective and preventive actions to ensure product quality, regulatory compliance, and continuous improvement.

Essential Duties and Responsibilities:

• Lead and support technical investigations related to manufacturing deviations, nonconformances, customer complaints, process failures, equipment issues, documentation discrepancies, and quality events.
• Conduct thorough root cause analysis using structured problem-solving tools such as 5 Whys, Fishbone, process mapping, and other applicable investigation methodologies.
• Review and analyze batch records, device history records, equipment logs, process monitoring data, maintenance records, inspection results, environmental monitoring data, and other relevant documentation to support investigation conclusions.
• Interview operators, technicians, supervisors, engineers, quality personnel, and other subject matter experts to gather accurate information related to investigation events.
• Assess product impact, process impact, and potential risk to patient safety, product quality, regulatory compliance, and business continuity.
• Document investigation findings in a clear, accurate, timely, and compliant manner in accordance with internal procedures, Good Documentation Practices, and applicable regulatory requirements.
• Support the development, implementation, and verification of corrective and preventive actions to address identified root causes and prevent recurrence.
• Collaborate cross-functionally with Manufacturing, Quality Assurance, Engineering, Maintenance, Validation, Regulatory Affairs, Supply Chain, and Operations teams to resolve technical and quality issues.
• Ensure investigations are completed within required timelines and escalate delays, high-risk issues, or significant quality concerns as appropriate.
• Ensures investigations are performed with sufficient rigor, objectivity, and documentation to support conclusions and withstand regulatory, customer, or internal review.
• Participate in Material Review Board, deviation review meetings, CAPA meetings, complaint review meetings, and other quality or operational forums as needed.
• Identify recurring trends, systemic issues, and opportunities for process improvement based on investigation data and quality metrics.
• Support audits and regulatory inspections by providing investigation records, rationale, technical explanations, and subject matter expertise as required.
• Assist in the review and improvement of standard operating procedures, work instructions, manufacturing documentation, and investigation processes.
• Maintain knowledge of applicable regulatory and quality requirements, including FDA Quality System Regulation, ISO 13485, GMP, GDP, and internal quality system procedures.
• Promote a culture of quality, compliance, accountability, and continuous improvement across manufacturing operations.

Additional Responsibilities:

• Provides a "Customer Service" attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Maintains a clean, orderly, and safe workstation and environment at all times.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and safety rules.

Education Preferred:
Associate's degree in engineering (industrial, chemical), quality or science.

Work Experience Minimum: 3+ years' work experience in the medical, pharmaceutical, or high-volume regulated manufacturing environment.

Preferred

Knowledge, Skills and Abilities:

• A working knowledge of quality systems such as ISO 13485/21 CFR Part 820 and EU GMP is essential.
• Ideally have a very good knowledge of Injection Molding (standard process and Multi component), Processing, Ancillary equipment, and automation systems.
• Ideally have…