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Director Quality Assurance - Utah

Job Title: Director Quality Assurance - Utah
Contract Type: Permanent
Location: International
REF: 88961
Job Published: over 1 year ago

Job Description

Contact: Bimi Felix
Telephone: 091730022

Director Quality Assurance - Utah
Our client, a medical device company in America are currently looking to recruit a Director Quality Assurance for their site.

Key Responsibilities
  • Key member of Senior Leadership Team that manages, develops and drives the company, (MMSI), to deliver the goals of the business i.e. Best in Class (Safety, Quality, Business Processes), Revenue Growth & New Business Development.
  • Sets strategy to enhance and maintain MMSI's Quality Assurance Programs, to meet the required regulations applicable to the processes managed, products produced, markets served e.g. US, Canadian, EMEA, Asia, CSR (Customer Specific Requirements).
  • Assigned Quality System Management Representative for the company; primary regulatory agency and customer contact on all quality related queries for the region e.g. compliance audits & follow up, customer complaints, quality agreements, and technical agreements.
  • Select, provide guidance, direction and supervision to Quality Assurance Personnel. Identify and make provision for required training to ensure proper and efficient completion of all quality assignments. * Develop and manage quality departmental budgets.
  • Promote, support the Business Excellence Program; lead by example; Partner with function leaders to ensure that this program and the organization values are at the forefront of decision making and action.
  • Partner with Global Quality Assurance Team and other company sites in the development of partnership systems for standard business, quality processes.
Qualifications/ Experience
  • Education and/or experience equivalent to a Bachelor's Degree in Quality Engineering/Engineering/ Science, or equivalent qualification essential (NFQ Level 7, or higher); Post graduate diploma/Masters in Quality Management desirable.
  • At least ten years of work related experience, of which a minimum of four years' experience in a related management role, coupled with a proven track record in leadership and development of a large team. * Proven track record in leading organizations through external inspections / audits (e.g. FDA, Notified Bodies, Competent Authorities, Customers), essential.
  • Working knowledge of and experience with U.S. FDA regulations, the Medical Devices Directive (93/42/EEC), Canadian Medical Device Regulation (CMDR) and JPAL/JGMP, ISO 13485 Quality System Standard and ISO 14971 Risk Management
  • PC skills including standard offices packages as well as ability to understand and learn customized computer software programs.
Competencies / Expectations
  • Strong Leadership ability, with presence and the ability to influence at all levels within the organization.
  • Demonstrated leadership skills including the ability to coach, assess, evaluate, develop, motivate and empower others.
  • Excellent communication (oral and written) and interpersonal skills with the ability to convey information and ideas in a variety of media, tactful, confident at all levels, internal and external.
  • Excellent data, analysis, trends, and reporting skills. Ability to read and interpret documents. Ability to write clearly and informatively technical documentation, routine reports, correspondence, procedures and work flows. Presents numerical data effectively. Attention to detail without losing site of the big picture.
  • Identifies and resolves problems in a timely manner; develops alternative solutions; works well in a group problem solving situations; presents ideas and information in a manner that gets others' attention; displays willingness to make decisions; exhibits sound and accurate judgment; supports and explains reasoning for decisions includes appropriate people in decision-making process
  • Strong project management skills, including the ability to prioritize, balance, and manage multiple efforts with strong results/goal orientation.
  • Demonstrated aptitude for process improvement and use of Lean and Six-Sigma resources and tools.

For further information on this Director, Quality Assurance role in America please contact Bimi Felix on 091730022 /
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