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Job Overview

Global Quality Director

Job Title: Global Quality Director
Contract Type: Permanent
Location: Colorado
Industry:
Reference: #9892
Contact Name: Phillip Hodson
Contact Email: phillip.hodson@kensingtonconsulting.co.uk
Job Published: September 17, 2020 09:06

Job Description

Job: Global Quality Director
Location: Colorado
Industry: Additive Manufacturing
Salary: Attractive salary and bonus scheme
Travel: 15-25%

Do you have a wealthy track-record in a quality function? Are you familiar with medical devices and the necessary accreditations? Is leading a team an aspect of your job that you enjoy?

A company that is recognised globally and who provides additive manufacturing solutions is hiring a Global Quality Director to join the business, and oversee teams across four different locations. They are looking for someone who can provide a clear strategy and vision aligned with business needs. Responsibilities will include staffing, performance evaluations, and career development, including setting employee objectives that link to initiatives and KPIs.

From a leadership perspective, you will take charge of the management review process, customer complaint system, the corrective and preventative action system, training, supplier quality, and internal audit system.

As well as this, you will provide the direction, coordination, education, and tools needed to achieve and maintain registration and compliance with the following standards: FDA QSR, European MDD/MDR, ISO 13485, AS/EN 9100, and other applicable ISO/EN standards.

Other responsibilities include:

  • Supporting internal and external audit activities, and function as subject matter expert for product complaints, CAPA root cause investigations and dispositions, and nonconforming materials processes.
  • Act as the focal point for ISO, Regulatory and Customer Audits of the Quality Management System. Partners with Engineering, Manufacturing, and R&D: Partner with internal stakeholders to ensure quality, compliance, customer satisfaction, patient safety, and continuous improvement.
  • Maintain strong understanding of design control and project management to ensure compliance.
  • Supports manufacturing, component, and non-conforming material investigations, as well as participates in other designated engineering projects.
  • Delivers on shared Quality/Operational goals (i.e. COPQ, scrap reduction, on-time delivery, and process improvements).

To qualify you will need a Bachelor’s degree, preferably in engineering and between 10-15 years of quality assurance experience within medical devices. At least 5-7 years of management experience in a quality function is also preferred. Ideally, you will have worked across multiple sites and also have to experience in a customer-facing role.

Candidates with experience working within systems compliant with FDA QSR, European MDD/MDR, ISO 13485, AS/EN 9100, and other applicable ISO/EN standards will be prioritized.

High level of competency in TQM, Six Sigma programs, DOEs, CQE/CQM preferred, and well versed in Lean Thinking. Experience or exposure to 5S Systems is a benefit.

Click to apply or speak to Phillip Hodson for further detail at phillip.hodson@kensingtonconsulting.co.uk / +44 (0)1257 268273