Impactful Quality Engineer: ISO/GMP & Audits

Tekni-Plex, Inc.; Ashland (MA); On-site; USD 80,000 - 85,000; Full time

Benefits offered by this job

Medical Coverage

Prescription Drug Coverage

Vision Coverage

401(k) Retirement Savings Plan

Daily Pay

Legal Plan

Identity Protection

Job summary

TekniPlex is seeking a Quality Engineer for the Ashland, MA facility to provide site‑level quality leadership and drive continuous improvement in product, process, and QMS performance.

You will ensure compliance with customer, ISO, GMP, FDA requirements and translate Voice of the Customer into actionable quality strategies, serving as the site Quality Authority and supporting cross‑functional teams.

Qualifications

• Bachelor’s degree in a technical field or 6 years quality experience in manufacturing.
• Experience implementing or supporting Quality Management Systems (eQMS preferred).
• Knowledge of ISO 13485, ISO 9001, GMP and FDA/21 CFR requirements is preferred.

Responsibilities

• Lead and improve the site Quality Management System (QMS).
• Oversee complaint handling, CAPA, changes, and document control.
• Coordinate internal, customer, and third‑party audits and follow‑up actions.
• Provide quality leadership across multiple functions and sites.

Skills

Quality leadership

Audit readiness

CAPA and root-cause

FDA/21 CFR knowledge

Risk management (FMEA)

Education

Bachelor’s degree in Engineering, Science, Quality, or related field

6 years quality experience in manufacturing

Tools

Intelex eQMS

Minitab

ERP systems

Job description

TekniPlex is seeking a Quality Engineer for the Ashland, MA facility to provide site‑level quality leadership and drive continuous improvement in product, process, and QMS performance.

You will ensure compliance with customer, ISO, GMP, FDA requirements and translate Voice of the Customer into actionable quality strategies, serving as the site Quality Authority and supporting cross‑functional teams.