Quality Manager, Operations
ICU Medical, Inc.

Position Summary

The Quality Manager, Operations will be responsible for directing, coordinating and managing quality operation and quality controls activities at the Salt Lake City Facility from raw material reception to final release of products. This role is responsible for ensuring processes involved in the manufacturing and inspection of molded, sub assembled and finished medical devices are performed in an environment that follows applicable procedures, industry standards and regulations.

This function oversees and lead the QA Controls teams that support the manufacturing for a high volume of molded components, assemble of components in high-speed assembly equipment, and manual assemblies and works on standardizing quality practices, identifies and provides quick resolution of quality events and promotes the implementation of actions to prevent reoccurrences. This role also oversees raw material incoming inspection, final acceptance activities to release products to sister sites and customer and the quality engineers that support parts testing and measurement systems.

Collaborate with other quality and operation functions to lead and support initiatives around improving QMS performance, GMP, GDP and Product performance monitoring activities.

Essential Duties & Responsibilities

1. Provide leadership to the Quality Supervisors and Quality Engineers directly supporting manufacturing and testing and measurement systems to ensure a proper right size structure and process is in place and maintained to ensure all Quality Control activities are completed on time and proper tools are in place for identification and resolution of product quality issues. If a nonconformity is detected, proper containment measures are implemented and will work with other functional areas to provide appropriate product disposition based upon data generated, specifications and technical judgment.

2. Develop, maintain and monitor the quality control activities to record, analyze, track and trend quality data to improve the measurement systems, methods and processes while using statistical and technical knowledge.

3. Partner with Operations, Supply Chain, Maintenance, Engineering and other Quality Functions to assess overall product quality performance, including the identification of any product-specific quality and compliance risks and develops mitigation plans and actions to address them, based on a risk-based approach.

4. Serve as Quality Operation representative to evaluate and authorize product & process changes after assessing impact and working with impacted areas to prepare for the change.

5. Recruit, train, lead and mentor direct reports

6. Review and approve documentation, including but not limited to Product Drawings/Specifications, Quality Operation Test Methods, Procedures, forms, Master Batch Record Activities, Validations Protocols and reports.

7. Assist with Customer, FDA and other regulatory agency inspections as needed.

8. 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.

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

10. 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

• 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.

• Data and trend analysis and reporting skills.

• Excellent 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.

• Excellent oral and written communication skills for effectively interfacing with internal and external areas and plants.

• 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 including; Quality System Regulations, 21 CFR 820, Canadian Medical Device Regulations, ISO 14971 and ISO 13485.

• Demonstrate a strong understanding and working knowledge of the Quality Sciences (Acceptance Sampling, SPC, continual improvement, Six Sigma, LEAN, Design of Experiments, COQ, Cause & Effect analysis etc.)

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

Education and Experience

• Bachelor's degree in sciences or technical are required.

• A minimum of eight years of experience is required; or equivalent combination of education and experience.

• 2-4 years of management experience

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

• Must be proficient in 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

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.