Description
Position Summary
The Product Configuration Regional Manager oversees all activities related to the administration of new product design and product change control as well as the implementation of approved product designs/changes for production within a particular geographic region. Ensures compliance with regulatory and manufacturing requirements related to product configuration and product change control. Overall leadership of change control teams at each site within the region.
Essential Duties & Responsibilities
• Manage all aspects of change control administration and the related employees within the region according to established change management and design control procedures
• Administrate, coordinate and manage project and change control requirements
• Maintain smooth and efficient operation of the Product Configuration team within the region
• Oversee the correct, complete, and compliant execution of Product Configuration activities
• Oversee the maintenance and accuracy of bill of material and router set ups
• Manage Change Control Review Boards, working closely with impacted functional areas to assess change and project impacts for manufacturing operations implementation readiness
• Ensure the smooth and accurate processing of new or changed device master records
• Maintain compliance with FDA, GMP, ISO and other applicable standards and regulations
• Maintain department SOP, WIs and applicable forms as required to comply with GDPs
• Assure department activities comply with establish SOPs, best practices, and GMPs.
• Assure all employees are properly trained and the training is correctly documented
• Resolve problems, investigate, analyze, propose solutions and resolve incidents, issues and exceptions
• Manage personnel and process performance key performance indicators (KPIs)
• Represent the Product Configuration team as a super user/subject matter expert, on company teams, and as a resource for other departments
• Coordinate activities with other supply chain and company departments.
• Actively lead, monitor, and promote development of team members. Identify training requirements and employee development growth strategies
• Develop and deliver employee reviews
• Other duties as assigned by management
Knowledge & Skills
• Excellent organizational and interpersonal skills required.
• High level of attention to detail
• Excellent verbal and written communication skills
• Ability to demonstrate proficiency in issue resolution.
• Ability to manage complicated tasks in a high pressure, fast paced environment.
• Ability to multi-task and work with little direction.
• Ability to delegate and manage multiple priorities.
• Advanced knowledge of FDA regulations, CGMP's, and ISO standards regarding product configuration
• Subject matter expert on labeling regulations and guidelines
• Knowledge and experience with pharmaceutical product labeling
• Proficient in Excel, Word, and Outlook
• Technically proficient with computer software programs, i.e. ERP systems, experience with specific programs relevant to this position
Minimum Qualifications, Education & Experience
• Must be at least 18 years of age
• Bachelor's degree from an accredited college or university is required
• Minimum 10 years of direct work experience in a medical device manufacturing company
• Minimum 5 years of experience in a documentation environment that includes authoring, processing and control of procedures
• ERP experience required, strong computer skills required, working knowledge of MS Office, strength in Excel.
Work Environment
• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office equipment.
• Typically requires travel less than 5% of the time
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.
What We Do
ICU Medical connects patients and caregivers through safe, life-saving, life-enhancing IV therapy systems, software, solutions, and consumables.
Since IV therapy is our only business, meeting your IV needs with quality products and consistent supply is our only concern. We are 100% focused on bringing you intuitive, patient-centric IV products and services that provide meaningful clinical differentiation, consistent innovation, and superior value. We design our products to work within your existing workflows to minimize disruption and maximize the time you spend with patients.
Together, we help forge the human and emotional connections that enhance clinical experience and are the essence of outstanding quality of care.
For more than three decades, we have been dedicated to a singular purpose—improving the safety and efficiency of IV therapy. With the acquisition of Hospira Infusion Systems from Pfizer in 2017, we became the only company to focus exclusively on IV therapy across the continuum of care.
Our focus allows us to bring you:
> Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
> The industry’s broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
> IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
> Significant US IV solutions manufacturing and supply capabilities.
