ICU Medical

Manager, Quality Systems

ICU Medical

full-time

Posted on:

Location Type: Hybrid

Location: Lake Forest • Illinois • 🇺🇸 United States

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Salary

💰 $93,750 - $134,375 per year

Job Level

SeniorLead

Tech Stack

Oracle

About the role

  • 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

Requirements

  • Ability to design and configure QMS software solutions based on industry leading practices
  • 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
  • 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.
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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
QMS software solutions designOracle EBSOracle Agile PLMGxP computer system validationbusiness process optimizationperformance monitoringenhancement projectstest script executionIT solutions architectureintegration efforts
Soft skills
leadershipcollaborationinfluenceteamworkcommunicationproblem-solvingproject managementprioritizationcontinuous improvementrelationship building
Certifications
ASQ Certifications