Manager, Quality Systems

ICU Medical Inc. • Lake Forest, IL

43d

About The Position

The Manager, Quality Systems will play an essential leadership role in the effective application of the Quality Management System, while ensuring compliance to regulations with respect to implementation, maintenance, monitoring and reporting of Quality IT applications. The incumbent will be responsible for the administration and management of the IT applications for various QMS subsystems (e.g. PLM, learning management, Complaint management, etc.), a function that is a critical asset in the product development and lifecycle management activities. These activities include identifying improvement opportunities in designated business applications, evaluating use cases and accordingly architecting IT solutions for the business to streamline the usage and implementation of the associated IT applications. Additionally, he/she is responsible for various aspects of the integration efforts associated with Quality IT applications and other projects related to the company's integration and standardization efforts. The incumbent will lead a team responsible for managing maintenance, enhancements, validations and performance monitoring of Quality IT applications.

Requirements

• Ability to design and configure QMS software solutions based on industry leading practices
• Experience in GxP computer system validation preferred
• Knowledge of Quality Engineering discipline; ASQ Certifications preferred
• Extensive knowledge of the function and department processes
• Knowledge of regulatory requirements: ISO13485, ISO14971, quality systems regulations (21 CFR: 820, 210 & 211), MDD, EU MDR, and other international regulations and standards.
• Computer software experience with specific programs relevant to this position.
• Bachelor's Degree from an accredited college or university (business, teaching, science/biology, Information Technology) required; and/or demonstrated equivalent experience with proven success.
• Minimum eight years of experience required, preferably in a regulatory, quality or compliance position of quality assurance experience in a related field
• Minimum of five years working in an environment which includes critical business systems and data analysis.
• 2-4 years of supervisory experience required
• Must be 18 years of age

Nice To Haves

• Experience with Oracle EBS, Oracle Agile PLM and business process optimization projects preferred
• Experience in GxP computer system validation preferred
• Knowledge of Quality Engineering discipline; ASQ Certifications preferred
• Knowledge of Quality Engineering discipline; ASQ Certifications preferred

Responsibilities

• Act as a business process owner for IT applications related to various QMS systems as it relates to product data, training, life-cycle management, complaint management, etc. (e.g. Agile PLM, PDH, iLearning (LMS), Trackwise Digital, etc.).
• Manage maintenance issues, enhancements, validations and performance monitoring of these Quality IT applications and integrations associated with other Oracle and non-Oracle IT applications.
• Lead a team involved in these activities.
• Ensure the managed systems meet all the requirements of the company, FDA, MDD/EU MDR and ISO and other applicable statutory and legal requirements and standards.
• Identify improvement opportunities in IT applications through management of maintenance issues and enhancement requests and architect IT solutions for the business(es) to streamline the overall usage and implementation of these applications.
• Ensure the IT solutions are appropriately architected to support the Quality Management Systems harmonization and improvement initiatives within ICU Medical. Accordingly, identify any improvement opportunities with associated IT applications and solutions.
• Lead project teams to design, develop and deploy IT solutions through various enhancement projects in IT applications.
• Manage the implementation activities of these applications including executing test scripts, implementing, and training end users.
• Establish priorities ensuring timely completion of enhancement projects in IT applications.
• Identify issues, dependencies and schedule risks and define tactical action plans to resolve and mitigate.
• Lead integration efforts associated with Quality IT applications and other projects related to the company's integration and standardization efforts.
• Recommend and coordinate QMS process improvements.
• Coordinate activities to ensure departmental compliance to all Federal, State, Local and Company regulatory requirements.
• Ensures that project/department milestones/goals are met and adhering to approved budgets.
• Drive continuous improvement efforts by facilitating, leading, and collaborating with cross functional teams
• Lead, collaborate, challenge and influence peers, direct staff and senior management
• Perform these and other duties as necessary or required
• Establishes effective working relationships in a team environment, which enables the ability to effectively influence the organization

Benefits

• Competitive financial benefits, including a generous 401(k) match and (for eligible roles) our Annual Incentive Plan
• A wide range of benefit options at affordable rates
• Additional perks to assist employees with their work-life effectiveness, such as Paid Time Off, Company Holidays, and Tuition Reimbursement

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Miscellaneous Manufacturing
• Number of Employees: 1,001-5,000 employees