Director QA, OEM

Position Summary

Provide strategic and tactical direction to OEM Quality Assurance, Quality Engineering and Quality Systems.  , for all locations under the OEM Business unit. Currently, 5 US locations and 1 location in Ireland. Leverage cross-functional teams within the business unit (OEM) and within Teleflex, including Regulatory Affairs and sister facilities to create an optimal customer experience. Work closely with other Business Units and Regions as appropriate.  Participates as a member of the OEM Business Unit Senior Leadership Team. The position can be remote, with routine visits to applicable facilities. 

Principal Responsibilities

•    Provide direction and leadership to quality assurance management to ensure that the quality of the product and the services are achieved, maintained, and improved. 
•    Support and ensure clear communication paths exist Provide direction and leadership to regulatory affairs personnel to ensure that products are legally registered in the applicable countries prior to distribution, and that OEM customer requests are supported.
•    Support Direct the creation, approval, and maintenance of global submission / registration documentation; design assurance and risk management documentation.
•    Ensure compliance to all relevant US and international regulations / laws as relevant to regulatory affairs, design assurance, and risk management.  Educate management and teams as needed.
•    Participate and support in FDA, notified body, supplier and/or other inspections / audits including internal activities.
•    Lead and / or facilitate communications with external agencies and internal teams.
•    Provide legal (regulation), statistical, and other SME support.  This may include completion of declarations, attestations, or other conformity assurance documents.
•    As a member of the business senior management team, participate in the formulation of the annual strategic and operating plans including BU objectives. 
•    Build, develop and manage a management team capable of implementing strategic initiatives, and best practices. 
•    Manage, train, coach, mentor, develop and review the work of assigned staff.
•    Maintain governing policies, procedures, work instructions, scorecard reporting etc.  Address any gaps as discovered.
•    Facilitate a resolution by leveraging cross functional involvements and implement a procedure that ensures the problem does not occur again, or recommends products or services to better meet customers' needs.
•    Assist corporate, SBU, or functional management with their responsibilities as required.
•    Adhere to and ensure the compliance to the Code of Conduct, all company policies, rules, procedures, and housekeeping standards, including Teleflex Core Values. 
 

Education / Experience Requirements

•    Minimum of Bachelor of Science degree required. Focus on business,  technical, engineering, or science discipline.
•    Minimum of 15 years of experience in manufacturing environment 
•    Minimum of 10 years’ experience in the medical device Quality environment in a manufacturing industry and 5 years of leadership experience required
•    A solid understanding of the medical device industry is required. Experience in Knowledge of the OEM and contract manufacturing market-place is strongly preferred a plus.  
•    Experience in a matrix management organization strongly preferred.
•    Broad regulatory knowledge base including OEM and contract manufacturing requirements for US and OUS including global requirements for: MDR, change assessment, complaint handling/adverse events, recalls, and quality systems etc required.
 

Specialized Skills / Other Requirements

•    Must possess superb time management skills and the ability to organize and manage multiple competing priorities 
•    Extensive capability in Microsoft Office, including Word, Excel, Powerpoint ,and Outlook, SharePoint and Teams.
•    High attention to detail and accuracy 
•    Strong business acumen
•    Ability to work well under deadlines and pressure
•    A results driven professional able to inspire others through vision with the ability to formulate and articulate ideas and action programs and lead them through execution.
•    A high-energy self-starter who thrives in a fast-paced, lean, entrepreneurial environment and will “roll up his/her sleeves” to get the job done.  
•    A team player that treats individuals with dignity and respect, enhancing and leveraging the effectiveness of others; maintains focus and keeps the team focused. 
•    A creative problem solver with a proactive attitude, motivated to set aggressive goals and be measured against them. 
•    Ability to communicate effectively, clearly, accurately, and directly, both verbally and in writing to establish credibility and confidence both internally and externally with customers at all levels.  Comfortable with customer face-to-face and communication on the manufacturing floor.  
•    Can conduct conversations at both the business and technical level and is able to communicate concepts with confidence vigor and firmness.

TRAVEL REQUIRED: 30 %
 

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