Senior Quality Engineer

Overview

TekniPlex Healthcare is a respected business partner that manufactures medical and pharmaceutical packaging. We aim to improve patient outcomes by enabling less invasive procedures, reduced pain, faster healing, and safer drug delivery. We are hiring for teammates in our Quality Department, located in Madison, WI.

Job Summary

The Sr. Quality Engineer will be responsible for ensuring product and process quality across manufacturing operations in accordance with internal standards and external regulations (e.g., ISO 13485, FDA). This individual will drive continuous improvement initiatives, support quality system management, and work cross-functionally to resolve issues and maintain compliance.

Responsibilities

• Quality Systems & Compliance : Support the development, implementation, and maintenance of the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and customer-specific requirements; participate in internal and external audits (e.g., FDA, ISO, customer).
• Process & Product Quality : Perform root cause analysis and CAPA investigations; review, approve and execute / support validation protocols, reports, and production documentation; conduct quality inspections, audits, and SPC; create and maintain FMEAs for processes; participate in and / or support supplier management (supplier approval, SCARs, audits).
• Documentation & Reporting : Create and revise quality procedures, work instructions, and control plans for new and existing machines; maintain accurate records of testing, inspections, and quality metrics; maintain raw material and internal product specifications.
• Continuous Improvement : Lead or support Lean / Six Sigma and continuous improvement projects; analyze process data to identify trends and areas for improvement; lead or support supplier management of change projects.
• Cross-functional Support : Collaborate with Engineering, Production, and Regulatory teams to ensure product quality throughout the development and manufacturing lifecycle; interface with customers on quality-related matters, including complaints and audits.
• General : Ability to support other Business Unit plants as needed; ensure quality standards and procedures are maintained, including training and monitoring of employees; oversee maintenance of test equipment (calibration, repair, servicing, supplies); perform other duties as assigned.

Qualifications

Language & Mathematical Skills

Reasoning & Physical Demands

Work Environment

Equal Opportunity

Tekniplex is proud to be an Equal Opportunity Employer. Our hiring practices provide equal opportunity for employment without regard to race, religion, color, sex, gender, national origin, age, veteran status, ancestry, sexual orientation, marital status, medical condition including genetic characteristics or information, or any other protected category under federal, state, or local law.

Note : The description above reflects current responsibilities and requirements; it may be adjusted to meet organizational needs.

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