Technical Investigator

About the Company

At West, we’re a dedicated team connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun.

We empower the physical, mental, emotional, and financial health of our team members and their families through comprehensive benefit programs. We believe in giving back to help those in need in the communities where we live and work and are committed to creating a healthier environment and planet through our sustainability efforts.

About the Role

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.

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.
• Ensure 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.
• 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.
• Perform other duties as assigned based on business needs and site quality objectives.

Requirements

• Minimum: 3+ years’ work experience in the medical, pharmaceutical, or high-volume regulated manufacturing environment.
• Preferred: Associate’s degree in engineering (industrial, chemical), quality, or science.

Skills

• 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.
• Excellent technical writing skills.
• Effective problem-solving skills and working knowledge of root cause analysis tools such as 8D and A3.
• Working knowledge of statistics and Data analytics, SPC, and ideally the use of statistical packages.
• Excellent communication skills both oral and written.
• Knowledge in computer systems; integrated manufacturing systems; word processing and spreadsheets.
• Ability to deal with all levels of employees and work across various departments.
• Able to comply with the company’s safety and quality policies at all times.

Work Environment

• Medical Device manufacturing requires strict adherence to standards.
• Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate fumes and particulate generated from various plastics.
• Work areas are equipped with adequate lighting, cooling/heating, and equipment that are in a good working condition.
• Must work constructively in an environment that may be stressful due to competing resources while maintaining company confidentiality.
• May stand or sit for extended periods of time.
• Must transport oneself to and from other areas of the facility and travel to other divisions when necessary.
• Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues.
• Hearing ability should be sufficient to hear audible alarms from distances up to 150ft.

Physical Requirements

• Medium-Exerting up to 50lb/22kg of force occasionally and/or up to 20lbs/9kg of force frequently, and/or up to 10lbs/4kgs of force constantly to move objects.