Global Technical Support Manager, Medical Device

Summary The primary role of this position is to provide strong leadership to the Product Support Team.  This position will ensure the proper level of support and direction to the Product Support Specialists and the Area IT so that their goals and objectives are met.  The Product Support Manager is accountable for compliance with applicable regulations governing feedback management, service documentation, service process controls, and field action management.  This position will balance day to day activities to ensure, support of the customer?s technical issues, resolving customer issues with leadership responsibilities and managing employee performance.  As a manager, there is the expectation that opportunities that improve customer service, profitability, process efficiency, and compliance are investigated and acted upon.  This role interacts with many different areas of the organization both domestic and international.

 Key Responsibilities & Duties

?  Ensure prompt escalation of all qualified unresolved issues to the appropriate PQT.

?  Work with R&D and Ops Engineering on issue investigations as required.

?  Ensure prompt reporting to the Regulatory Affairs group of possible patient incidents.

?  Ensure product and process feedback is accurately recorded into the appropriate systems.

?  Establishing, reviewing and reporting all appropriate performance measurements.

?  Oversee timely completion of Field Actions/Product Recalls.

?  Advocate customer satisfaction by championing the need for corrective and preventative action.

?  Structure work, design efficient and effective work processes and environment.  Delegates decisions and empower employees to provide world class support to our customers.

?  Participating in cross-functional teams as required.

?  Agreeing and operating within the Team?s annual budget.

?  Ensure processes are examined, validated and documented to meet the needs of the customer and the organization, as well as conform to FDA quality system regulations.

?  Development of supplementary policies, procedures and processes as required.

?  Select and develop employees.  Select diverse, highly skilled people and provide departmental resources and opportunities.  Mentor and assist employees in career planning.

?  Inspire team performance.  Set goals and expectations.  Monitor progress and course corrections.  Reward outcomes.

?  Review documentation and communications produced by the group and business areas to ensure compliance to organizational and regulatory standards.

?  Other duties as required.

 Qualifications

?  Bachelor degree in job related field, or Associate degree and/or 8 years experience in related field. 

?  Minimum of 5 years experience in product support, technical support, customer support product development, project management, IT, quality assurance or regulatory affairs of which 3 years must be in a supervisory/management role.

?  Prior IT hardware/software experience and clinical background desirable.

?  Proficient with Microsoft Office and Lotus Notes applications. Experience with Visio and PowerPoint desirable.

?  Highly self motivated and ability to manage multiple projects.

?  Advanced level of personal communication skills; electronic, written, and oral is required.  Technical writing skills preferred.  Ability to speak in front of large audiences.

?  Strong leadership skills with the ability to motivate and develop others.

?  Flexibility with work hours required as scheduling may vary according to the needs of the customer or the organization. 

?  Occasional travel required both domestic and international, less than 40%.