ICU Medical Director, Quality – Service and Investigations in Salt Lake City, Utah
Director, Quality – Service and Investigations
The Director, Quality oversees the administration of Service Quality, and Investigations of Complaints. This role ensures that the quality system requirements are established and met for, post market investigations and field service areas. Also promotes the awareness of regulatory and customer requirements throughout the Service organization. Administers, directs and coordinates pump service centers and field service teams in the USA, Canada, APAC/Asia, LATAM and EMEA regions providing worldwide service/repair of serialized medical devices. This includes providing Global leadership to achieve a customer-focused organization along with the Quality Assurance strategic oversight and guidance to all global field service locations. This role partners with the Global Pump Service and Manufacturing Vice President to set the vision of the Pump service business worldwide. In addition, this role partners with commercial leaders of various business units, regions along with quality leaders in various regions to address customer concerns and provide appropriate communication on investigations. This role also oversees the post market risk evaluation and field action decision making process.
Essential Duties & Responsibilities
• The global role includes significant cross-functional and multisite responsibilities with employees reporting through subordinates. Also includes strategic management of third party service providers.
• This position requires a strong tactical decision maker to handle customer issues. This position will provide internal and external oversight vigilance related to cGMP compliance of all activities required for investigations and device service activities
• Frequently interacts with clinical customers in resolving issues.
• Manages the post market risk evaluations and field action decision making process
• This position will lead the regulatory compliance process including all regional service centers and field service locations in all cGMP initiatives. Requires in-depth knowledge of the functional area, business strategies and the company’s goals.
• This role is considered a SME on several business and compliance-related topics. Direct relationship and interaction with regulatory agencies worldwide is expected.
• Regularly interacts with senior level leaders and corporate executives involving skills such as negotiating and influencing leaders regarding matters of significance to the organization.
• Leads and directs the QA global pump service organizations and ensures ICU regional service centers maintain their QA systems in accordance with global policies and procedures.
• Provides direct interface/liaison with all Regulatory functions both internal and external agencies such as FDA, BSI, NSAI, and CSA.
• Establishes and administers a transparent global pump service compliance program including periodic audits of ICU Medical, 3rd party and Dx service providers.
• Ensures development and alignment of annual site goals and objectives while overseeing progress to ensure project deliverables are met on time and within budgeted cost parameters.
• Develops strategies, tools and expertise in data analysis to evaluate service and complaints data for appropriate trends and triggers to identify developing areas of concern proactively and in a timely manner.
• Identify areas requiring quality improvement and initiatives and follow through on action plans necessary for implementation
• Support Development/Operations Engineering and Manufacturing to resolve technical issues
• Accomplish results through subordinates
• Responsible for high performance team building, identifying resource gaps, and working in collaboration to create personal development plans to enhance the capabilities of the department
• Develop, manage and execute Quality Plans
Knowledge, Skills & Qualifications
• Must be able to apply GMP principles to risk management, production and process controls, and other pertinent elements of the Quality System
• Must have knowledge of Quality Engineering discipline, including statistics; ASQ Certified Quality Engineer preferred.
• Strong Quality Auditing principles.
• In-depth knowledge of FDA QSR, MDSAP, MDR and other international quality system regulations
• Strong working knowledge of DMAIC / Six Sigma problem solving process
• Proven track record of initiating and driving continuous improvement. Team-oriented and able to lead and influence without authority. Team building and collaborative leadership skills are necessary.
• Strong leadership skills with experience interacting with external customers, and demonstrated critical thinking skills necessary to quickly identify risk and potential solutions to improve customer satisfaction and product performance.
• Must be flexible with strong communications kills, ability to breakdown complex issues into actionable topics.
• An outside the box thinker with positive attitude focused on problem solving and continuous improvement.
Education and Experience
• Bachelor’s degree in Sciences or engineering. Masters preferred.
• 7-10 years experience with a combination in the following disciplines: Quality Engineering/Assurance Management; Engineering Manager/Manufacturing and Operations Management
• Combination of CQE, CQA, CMQ/OE, SSGB/SSBB preferred
• Managerial experience in one or more of the following: Quality, Engineering, Manufacturing Operations or Technical Customer Service and Support
• Direct experience with medical devices and regulatory environments (i.e. QSRs, MDD, MDR, ISO9001, ISO13485, etc.) is required
• Experience with FDA inspections and successful track record with inspection outcomes
• Demonstrated success in developing, mentoring and managing technical teams
• Must be at least 18 years of age
• Typically requires travel 30% of the time
Physical Requirements and Work Environment
• Work is performed in a professional office environment and is largely a sedentary role.
• Routinely uses standard office equipment (i.e. computer / laptop) and will sit for extended periods of time.
• Job requires travel both inside /outside US and will be required to sit for extended periods of time on aircraft.
ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Title: Director, Quality – Service and Investigations
Location: UT-Salt Lake City
Requisition ID: 20300645