Job Description:

Job Description



Essential Duties & Responsibilities


1. Provide management and development to Quality Engineers responsible to conduct the process validations for Molding, Automated Assembly Equipment, Manual Assembly, Test methods, Testing and Laboratory Equipment.

2. Provide influential peer and managerial leadership to drive proactive quality improvements to QMS processes.

3. Proactively drive continuous improvement activities to ensure problems are prevented and issued resolved efficiently and economically.

4. Represent Quality Organization as a core team member on business team and projects review and to properly assess quality strategy for them.

5. Able to conduct internal audits and to act as the face and lead during regulatory and customer audits for the facility.

6. Review and approve documentation, including but not limited to Change Control Assessments, QMS Procedures, Validations Protocols and Reports, Product Specifications, Test Methods, Audit Reports, CAPAs and Nonconformances.

7. Develop, implement and monitor Key Performance Indicators (KPI) to assess performance of validation program for the facility. Able to highlight trends, risks and opportunities for improvement and to drive resolution.

8. Partner with Operations, Advance Manufacturing Engineering (AME), Supply Chain, Maintenance, Engineering and other Quality Functions to work on projects to improve company revenue, process and product quality improvement, manufacturing efficiencies, reduce supply risk or address compliance risk.

9. Recruit, train, lead, retain and mentor direct reports and able to identify and implement changes to existing organization structure to better support the manufacturing site.

10. Assists the Site Quality Leader in the developing, recommending and implementing of section and departmental goals and objective policies, budgets and plans for defining the effective utilization of the Quality Organization resources.

11. Conducts GMP Training for plant employees to assure employee awareness of their responsibility to GMP compliance.

12. This position is required to work collaboratively with other function within the organization to identify and prioritize tasks required to achieve business goals associated to these projects.



Knowledge, Skills & Qualifications


• Practical knowledge of validations including molding processes, assembly equipment, manual assembly, software, laboratory equipment, test methods.

• Strong analytical, problem solving and decision making skills.

• Proven track record of cross-functional collaboration across teams and change management skills.

• Able to make decision, set priorities and complete projects and tasks with minimum supervision.

• Ability to influence others at all levels within the organization using right leadership approach, proper negotiation skills and able to work in a team environment.

• Acts with urgency and passion in a fast-paced environment. Enjoys helping others.

• Good organizational and time management skills with a high level of attention to detail.

• Presentation Skills, result oriented. Must be able to relate and communicate effectively to other departments inside and outside of the SLC plant and supervise in an effective manner the performance of resources allocated to the area of responsibility to ensure the required outcome is achieved.

• Strong verbal oral and written communication skills for effectively interfacing with internal and external areas and global functions.

• The incumbent will have full responsibility for decisions within normal boundaries. Decisions will naturally be consistent with business objectives, but technical decisions are generally made independently.

• The incumbent is expected to be proactive and to develop and effectively administrates his/her portion of projects, resources, and roles responsibilities. The incumbent will routinely encounter conflicting priorities that need timely resolutions and will require constant revision to remain consistent with program objectives and customer delivery commitments.

• Follows regulations, norms and procedures. Promptly responds to customer's requests / Customer Focus.

• Knowledge of national and international regulations applicable to medical devices such as US Quality System Regulations 21 CFR 820, Risk Management ISO 14971 and ISO 13485.

• Demonstrate a strong understanding and working knowledge on parts drawing interpretation, Critical Quality Attributes (CQA) and the Quality Sciences (Statistical process Controls, Acceptance Sampling, Capability Analysis, Six Sigma, Design of Experiments, Cause & Effect analysis etc.)

• Experience writing, reviewing and/or approving quality documents.



Education and Experience


• Bachelor's degree in engineering required.

• Minimum of eight years of industry experience is required

• 2-4 years of management experience

• Prior experience in medical device manufacturing environment coupled with certifications from ASQ preferred.

• Must be proficient in Minitab or other statistical software, Microsoft Excel, Word, PowerPoint, and Outlook



Physical Requirements and Work Environment


• While performing the duties of this job, the employee is regularly required to talk or hear.

• This job operates mainly in a professional office environment and controlled manufacturing areas requiring special gowning.

• This job requires computer work for hours at a time, along with standing and walking.

• Typically requires travel 10-20% of the time



About Us



ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.


With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.


We're ready to bring you consistent quality, innovation, and value in more areas than ever. 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.

ICU Medical EEO Statement:


ICU Medical is committed to fostering a diverse, inclusive, and equitable work environment. As an Affirmative Action and Equal Opportunity Employer, we ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender identity, gender expression, gender reassignment, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.


If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.


ICU Medical EEO Policy Statement



OFCCP Equal Opportunity Posters

"Know Your Rights" Poster
Pay Transparency Nondiscrimination Provision


ICU Medical CCPA Notice to Job Applicants Apply Now