Demo

Head of Quality Assurance and Compliance

Envista
Quakertown, PA Full Time
POSTED ON 4/21/2025
AVAILABLE BEFORE 5/5/2025

Job Description

This role is responsible for leading the Quality Engineering and Complaint Handling/Post-Market Surveillance teams in executing quality strategies for sustaining and new products. The position requires strong leadership and communication skills, as well as a deep understanding of regulatory requirements and industry standards.

Main duties and responsibilities:

  1. Lead the development and implementation of quality strategies for sustaining and new products.
  2. Supervise and coach staff members in their roles and responsibilities.
  3. Oversee post-market data and drive KPIs to targets.

Required qualifications include a Bachelor's degree in a relevant field, 5 years of experience in the medical device industry, and 3 years of direct supervisory and decision-making experience. Additionally, knowledge of FDA regulations, ISO 13485 MDSAP, EU MDR is required.

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