Quality Engineering Manager

4 days ago


Cincinnati, Ohio, United States Integra LifeSciences Full time

Quality Engineering Manager Job Summary

Integra LifeSciences is seeking a Quality Engineering Manager to join our team. As a Quality Engineering Manager, you will be responsible for managing the Product Quality Engineering group focused on product compliance in support of Product Design and Manufacturing.

Key Responsibilities:

  • Management of Quality Engineering Activities (including process validations, complaint investigations, CAPA investigations, Product hold management, design/manufacturing change support, inspection plans, test method validations).
  • Management of key Quality Management System elements including Control of Nonconforming Product, Complaint Investigations, Inspection and Test and CAPA.
  • Management and mentoring of Quality Engineering personnel and Quality Control Inspection team.
  • Quality Engineering representative during Management Reviews and audits (internal and external).
  • Member of Internal Audit Team.
  • Other Quality duties as assigned by Director of QA Operations.

Requirements:

  • Bachelor's degree in Quality Assurance or Engineering or related discipline.
  • At least five (5) years of experience in the Medical Device Industry or related industry.
  • Experience in personnel management and mentoring.
  • Demonstrated experience in successfully leading a team.
  • Experience in project management.
  • Experience with measurement systems and statistical techniques.
  • Working knowledge of QA Engineering related QMS elements including Design Controls, Production and Process Controls (including Process Validation), Control of Nonconforming Product, Facilities/Environmental Controls, Labeling and Packaging Controls, Handling, Storage, Packaging and Distribution of Product.
  • Ability to interface with top organizational leadership and internal and external customers, responding in a professional manner.
  • Ability to communicate effectively (both written and oral).
  • Ability to influence positive change effectively.
  • Exceptional conflict-resolution skills.
  • Experience with development and implementation of quality system procedures.
  • Certified Quality Engineer (e.g., ASQ CQE)
  • Certified Auditor or relevant experience.
  • Experience and expertise in Document Controls processes.
  • Experience with Trackwise, Oracle and Power BI are a plus.


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