Director, Quality – Service and Investigations

AMERICAN CYBER SYSTEMS INC - Director, Quality – Service and Investigations

Location: SALT LAKE CITY, Utah

The Director, Quality plays a vital role by overseeing the administration and investigation of global complaints related to consumables and serialized medical devices. This position is accountable for ensuring that quality system requirements are effectively established and maintained across post-market investigations and service operations.

In this role, the Director promotes awareness of regulatory and customer requirements throughout the organization and provides global leadership to ensure a customer-focused approach to managing on-market product issues. They are responsible for administering, directing, and coordinating activities across manufacturing sites, pump service centers, and field service teams across the USA, Canada, APAC/Asia, LATAM, and EMEA regions. This ensures consistent and high-quality investigations, servicing, and repair of medical devices on a global scale.

The Director collaborates closely with senior leadership on the vision and execution for global consumable investigations and the capital equipment service business. They work in partnership with commercial and quality leaders across various business units and regions to address customer concerns, facilitate effective communication, and manage the post-market risk evaluation and field action decision-making processes.

Overall, the Director, Quality provides strategic oversight and guidance for all investigative activities, driving excellence in quality assurance and ensuring exceptional service delivery across the globe.

Key Responsibilities

1. Cross-Functional and Multisite Responsibilities: Oversees global operations with employees reporting through subordinates and manages third-party service providers.
2. Strategic Planning: Works closely with VP of Post Market Quality and other cross-function leaders to define and execute strategic initiatives.
3. Tactical Decision Making: Handles customer issues and provides oversight for cGMP compliance in investigations and device service activities.
4. Customer Interaction: Frequently resolves on-market issues with clinical customers.
5. Post-Market Risk Management: Supports risk evaluations and field action decisions.
6. Regulatory Compliance: Leads regulatory compliance efforts across all regional service centers and field locations, requiring extensive knowledge of business strategies and company goals.
7. Subject Matter Expert (SME): Acts as an SME on complaint investigation and service activity topics. Direct relationship and interaction with regulatory agencies worldwide is expected.
8. Senior Leadership Interaction: Regularly negotiates and influences senior leaders and corporate executives regarding matters of significance to the organization. Responsible for reporting on and providing status of key metrics and ongoing quality issues.
9. Global QA Leadership: Directs the global QA capital service organization and ensures regional service centers adhere to global QA policies.
10. Regulatory Liaison: Interfaces with regulatory bodies such as the FDA, BSI, NSAI, and CSA.
11. Compliance Program Management: Establishes and manages a global compliance program, including periodic audits of internal and third-party service providers.
12. Goal Setting and Oversight: Develops and aligns annual site goals, ensuring projects are completed on time and within budget.
13. Quality Improvement: Identifies areas for improvement and implements necessary action plans.
14. Technical Support: Assists Development/Operations Engineering and Manufacturing in resolving technical issues.
15. Team Building: Ensures high performance in team building, identifies resource gaps, and creates development plans to enhance department capabilities.
16. Quality Plans: Develops, manages, and executes Quality Plans.

Knowledge, Skills & Qualifications

1. Must be able to apply GMP principles to risk management, production and process controls, and other pertinent elements of the Quality System.
2. Must have knowledge of Quality Engineering discipline, including statistics; ASQ Certified Quality Engineer preferred.
3. Strong Quality Auditing principles.
4. In-depth knowledge of FDA QSR, MDSAP, MDR and other international quality system regulations.
5. Strong working knowledge of DMAIC / Six Sigma problem-solving process.
6. 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.
7. 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.
8. Must be flexible with strong communication skills, ability to break down complex issues into actionable topics.
9. An outside-the-box thinker with a positive attitude focused on problem-solving and continuous improvement.

Education and Experience

1. Bachelor's degree in Sciences or Engineering. Master's preferred.
2. 13+ years experience with a combination in the following disciplines: Quality Engineering/Assurance Management; Engineering Manager/Manufacturing and Operations Management.
3. 6+ years of supervisory experience in one or more of the following: Quality, Engineering, Manufacturing Operations or Technical Customer Service and Support.
4. Combination of CQE, CQA, CMQ/OE, SSGB/SSBB preferred.
5. Direct experience with medical devices and regulatory environments (i.e. QSRs, MDD, MDR, ISO9001, ISO13485, etc.) is required.
6. Experience with FDA inspections and successful track record with inspection outcomes.
7. Demonstrated success in developing, mentoring, and managing technical teams.

Minimum Qualifications

Must be at least 18 years of age.

Travel Requirements

Typically requires travel 30% of the time.

Physical Requirements and Work Environment

1. Work is performed in a professional office environment and is largely a sedentary role.
2. Routinely uses standard office equipment (i.e. computer/laptop) and will sit for extended periods of time.
3. 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.