Quality Engineering Site Manager

Our client, a publicly-traded, multinational medical technology company is currently seeking a Quality Engineering Site Manager to join their team. This person will be responsible for managing the Quality Engineering department and resolving manufacturing issues by implementing effective solutions and continuous improvement projects.

Responsibilities:

  • Manages QE department and overall expectations pertaining to setting accurate schedules, costs and resources
  • Ensures department is adequately resourced and trained to perform jobs effectively
  • Directly supervise QE staff including coaching and developing to enable maximum performance and individual employee growth, providing regular performance review and feedback and using corrective action as necessary.
  • Maintain company compliance of FDA Quality System Regulations and ISO:13485 standards
  • Identify and resolve issues in the manufacturing of Class III PMA medical device products, by designing and conducting Quality Engineering investigations, and working directly with manufacturing engineering, operators, and other plant personnel.
  • Oversee the Material Review Board (MRB), which includes providing leadership and coordination of activities for the investigation and disposition of non-conforming product and/or components.
  • Conducts design-related failure and hazard analysis for manufacturing support and supplier process improvements
  • Review and approve validations (IQ/OQ/PQ) and qualification studies as needed for new/existing equipment (inspection & process), software, components, etc.
  • Manage CAPAs and Audit Action Plans to completion using risk analysis, project management, and proper effectiveness verification methods
  • Revise procedures as needed based on nonconforming material investigations, CAPA, complaints, continuous improvement projects (CIP), and compliance to local, division, and corporate procedures, in addition to local and international quality regulations.
  • Represent the Quality function on committees, teams, task forces as assigned

Qualifications:

  • B.S Degree in Engineering required or bachelor’s degree in technical area, Master’s Degree preferred
  • 5+ years within medical device industry, preferably in Class II/III manufacturing environment
  • High level of competence in Quality Technology including statistical techniques, control charts, sampling plans, process capability, process/equipment validation, Gage R&R, design of experiments, correlation and regression, analysis of variance, probability, etc.
  • Strong statistical software and MS Project skills.
  • Ability to motivate people and mentor engineers
  •  Understanding of ISO 13485, MDD/MDR, GMP, QSR, and other applicable regulations, and the ability to interpret these as they apply to company issues.
  • Proven leadership skills in a fast-paced environment. Working knowledge of GMP and FDA regulatory requirements for Class III medical devices or equivalent
  • Experience in medical device Class II/III environment preferred
  • ASQ Certified Quality Engineer and/or Six Sigma Black Belt preferred
  • ASQ Certified Quality Auditor or equivalent preferred

If you are interested in this position, please send your resume to apowell@daleyaa.com

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