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Director of Quality/Site QA Leader

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, United States of America
Job Type
Direct Hire
Jan 19, 2017
Job ID

Director, Quality

Role Purpose:
The Site Quality Leader is responsible for all Quality activities at the Puerto Rico facility.  The incumbent will serve as Management Representative for the Quality System and lead the following functions: Quality Systems, Quality Engineering, Regulatory Compliance, Laboratory Operations, Product Release, Complaints Investigations, Internal Audits, Receiving Inspection and Supplier Quality.
This position reports directly to the VP of Quality for the business unit and dotted line to the VP/GM for the Puerto Rico Site, and is a key member on both the Product Quality Leadership Team and the Site Leadership Team. In addition, this position will represent the Site on the Product Operations Quality Council, teaming with the Site Quality Leaders from the Dominican Republic, Irvine and Amsterdam to drive harmonization and best practice adoption across the sites. 
Accountable to adhere to Corporate Environmental, Health and Safety and Quality System requirements to ensure our products and service consistently meet applicable customer and regulatory requirements.
Job Functions
Essential Job Functions % of time
Participates as a fully engaged member of both the Corporate Product Quality and Puerto Rico Site Leadership Teams
Acts as Management Representative for the Quality System, ensuring appropriate management controls are in place including effective internal audit and CAPA programs, as well as conducting routine Quality Managing Reviews
Ensures safe and effective products are manufactured at the Puerto Rico site in compliance with all applicable regulations, partnering with Operations and other functions on continuous improvement initiatives
Represents the Puerto Rico Site on the Product Operations Quality Council, teaming with the Site Quality Leaders from the Dominican Republic, Irvine and Amsterdam to drive harmonization and best practice adoption across the sites
Ensures a highly effective and motivated team is in place to meet the needs of the business, including staffing, training, performance management and personnel development
Serves as the site leader for regulatory activities, supporting the Regulatory Affairs Team at the business unit level
       Ensures management controls are in place to maintain an effective quality system,      
       conducting periodic Management Reviews and leading a robust internal audit program
Manages the budget in alignment with the needs of the business and supports value engineering activities to continual reduce product cost
Marginal Job Functions  
  • Leads or supports other teams, projects and activities as assigned
Required Education/Skills/Experience: 
  • Bachelor's degree in engineering or a related technical field (MBA or Master’s degree in engineering or related technical field preferred)
  • Minimum of 10 years related experience in the medical device industry with at least 7 years management experience
  • High energy, results oriented leader with excellent collaboration, teaming and project management skills
  • Sound judgment and decision making capabilities in technical, business and regulatory compliance arenas, with strong working knowledge of domestic and international regulatory compliance requirements (e.g. FDA QSR and ISO/EN standards)
  • Deep Quality Engineering toolbox including Design of Experiments, Process Capability Studies, Failure Mode and Effects Analysis, Statistical Process Control, Industrial Statistical Methods, Six Sigma and Lean Manufacturing (Black Belt desired)
  • Experience with Laboratory Operations and Regulatory Affairs, as well as experience leading internal audit programs and managing external audits (e.g. FDA, Competent Authorities, Notified Bodies) . Experience addressing FDA 483 items and regulatory actions.