Technical Investigator

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 excellent technical writing skills. Must have effective problem-solving skills and working knowledge of root cause analysis tools such as 8D and A3.Must have a working knowledge of statistics and Data analytics, SPC, and ideally the use of statistical packages. Must have excellent communication skills both oral and written. Must have knowledge in computer systems; integrated manufacturing systems; word processing and spread sheets. Must have excellent written and verbal communication skills as well as the ability to accurately document work performed. Must be able to deal with all levels of employees and work across various departments. Able to comply with the company's safety policy at all times. Able to comply with the company's quality policy at all times. License and Certifications:

Travel Requirements: None: No travel required

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.

Additional Requirements: 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 at all times 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.

What We Offer: West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.