Title:  Technical Investigator

Job Summary

Reporting to the Value Stream Lead within Operations, the Senior Associate Technical Investigator serves as a site‑level technical leader for complex problem solving, systemic non‑conformance reduction, and continuous improvement. This role drives high‑quality investigations, ensures compliance with the Quality Management System, and champions proactive, data‑driven improvements across operations. The Senior Associate partners with cross‑functional leaders to strengthen process capability, prevent recurrence, and enhance product and process robustness in a regulated medical device environment.

Essential Duties and Responsibilities

• Leading and facilitating complex, multi departmental investigations to ensure accurate root cause identification and the development of robust, sustainable corrective and preventive actions that eliminate recurrence and strengthen quality systems.
• Serving as technical subject matter resource on investigation methodology, elevating the consistency and efficiency of the site’s problem solving processes.
• Ensuring all investigations meet or exceed internal Quality standards, regulatory requirements and industry best practices.
• Driving advanced date gathering, trending, statistical analysis and performance monitoring to identify systemic issues, process variability and opportunities for proactive improvements before defects occur.
• Deploying Lean, Six Sigma and advanced problem solving tools and coaching others in their effective use to build problem solving capability throughout the organization.
• Acting as owner for investigation of related processes, recommending and implementing improvements in templates, workflows, documentation standards and training content.
• Ensuring timely, complete and well supported documentation of investigations, CAPAs and associated risk assessments in alignment with compliance requirements and business needs.
• Supporting and guiding peer investigators, providing mentorship and technical feedback to enhance investigation quality.
• Representing investigations during internal and external audits, providing clear and confident justification of root cause, corrective actions and verification of effectiveness.
• Collaborating closely with Engineering, Quality, Operations and Supply Chain to drive rapid closure of day to day quality issues, effective troubleshooting and alignment on long term solutions.
• Proactively identifying improvement opportunities related to process robustness, documentation quality, equipment performance, operator error proofing and automation.
• Acting in accordance with company Guiding Principles, Code of Conduct, and all EHS requirements.

Education

• Must have a Bachelor’s degree in Engineering, Quality, Science, or related discipline.

Work Experience

• Must have 8+ years’ work experience in the Medical, Pharmaceutical, or high-volume regulated manufacturing environment with at least 5 years directly involved in investigations, quality engineering, or process engineering roles.

Preferred Knowledge, Skills and Abilities

• Advanced understanding of injection molding processes (standard and multi‑component), molding equipment, tooling, automation systems, and key process parameters.
• Demonstrated excellence in technical writing, with the ability to produce clear, persuasive, and audit‑ready documentation.
• Proficiency with advanced root‑cause tools (8D, A3, Ishikawa, 5 Why, FMEA) and ability to coach others in their application.
• Solid understanding of statistics, data analytics, SPC, control charts, and statistical software packages.
• Strong communication skills, with the ability to influence cross‑functional stakeholders and facilitate effective technical discussions at all levels.
• High proficiency in computer and digital systems, including integrated manufacturing systems, data visualization tools, and standard business software.
• Ability to manage multiple complex tasks simultaneously, work independently, and make sound, timely judgments.
• Strong interpersonal skills with proven ability to work across departments and influence without authority.

Travel Requirements

• Must be able to travel up to 5% of the time or when required.

Physical and Mental Requirements

• Ability to work in a fast‑paced manufacturing environment while maintaining accuracy and composure.
• Strong organizational skills, attention to detail, and self‑motivation.
• Ability to collaborate cross-functionally in a matrixed environment and manage competing priorities.
• Ability to maintain confidentiality, resolve conflicts, and handle sensitive issues with professionalism.
• Demonstrated ability to make independent, data‑driven decisions.

Shift

M-F Days