Senior Quality Manager

3 weeks ago


Middletown, Connecticut, United States Datwyler Full time

Job Summary

The Head of Quality Management USA is responsible for ensuring the overall quality of our Healthcare Solutions sites in Middletown, DE and Pennsauken, NJ. This includes 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

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

Our Offer to You

  • Medical Benefits - eligible on 1st day of employment.
  • Dental Benefits.
  • Vision Benefits.
  • 401(k) retirement program.
  • Company-paid Term Life and Accidental Death & Dismemberment.
  • Option to purchase additional Life insurance.
  • Short/Long Term Disability.
  • Paid Time off (vacation).
  • Paid Time off (sick).
  • Twelve (12) paid holiday.
  • Flexible Spending Accounts.
  • Employee Assistance Program.

Join Our Team

We are convinced that people make the difference. At Datwyler, you'll experience diversity and a wide range of career opportunities that only an international company can provide. Together, we are increasing our agility, accelerating digitalization, and fostering sustainability. For motivated and talented employees, we offer interesting development opportunities with training and assignments in a global environment. With us, you can contribute with all your creativity and all your ideas.



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