Head of Quality Management

2 days ago

Middletown, United States Datwyler Full time

Job Summary

The Head of Quality Management at Datwyler is responsible for ensuring the overall quality of our healthcare solutions sites in Middletown, DE and Pennsauken, NJ.

This role will lead and manage the Quality department at our Healthcare sites, guaranteeing continuity of quality processes and activities according to global and local standards at an acceptable cost.

Key Responsibilities

  • Lead and manage the Quality department at our Healthcare sites in Middletown, DE and Pennsauken, NJ.
  • Manage the Quality Management Systems at both sites, maintaining the QMS and ensuring continued certification according to the requirements of ISO 9001 and ISO 15378.
  • Collaborate with management and senior staff at the sites to achieve the sites' objectives and increase quality awareness.
  • Coordinate and participate in internal and external audits, managing the results of such audits.
  • Take final responsibility for quality-related matters with customers, including review and approval of quality agreements and management of customer quality complaints.
  • Review and approval of deviations, change control requests, validation documents, and specifications.
  • Support the Quality Control teams to ensure proper testing for incoming materials, in-process controls, and final release of finished goods.
  • Define and implement projects to significantly improve the Quality/compliance level.
  • Contribute to global Quality initiatives to define or optimize global Quality standards.

Requirements

  • Minimum 5 years of proven experience in a Quality leadership position within a cGMP regulated environment.
  • Bachelor's Degree required, preferably in a science or engineering-related field.
  • Thorough knowledge of cGMP regulations, ISO 9001, ISO 15378, and current industry practices.
  • Good knowledge of domain-specific legislation, standards, rules, and procedures.
  • Fluent in English, both verbal and written.
  • Experience in a customer-facing role desirable.

About Datwyler

Datwyler is a high-tech company that focuses on high-quality, system-critical elastomer components and holds leading positions in attractive global markets such as healthcare, mobility, connectivity, general industry, and food & beverage.

We are committed to a comprehensive employee benefit program that helps our employees stay healthy, feel secure, and maintain a work-life balance.

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