Supervisor, Quality

Position Summary

The Quality Supervisor will supervise and coordinate the functional activities of QA non-exempt personnel, to oversee inspection, testing, disposition, and control of components, materials, subassemblies, final product, returned product, and documentation retention. The Quality Supervisor will support manufacturing operations and engineering in the objective of producing a quality product in a timely, efficient and economical manner. They maintain and ensure manufacturing and QA conformance to internal specifications and to GMP regulatory requirements. This position will write, implement, and enforce standard operating procedures and safety rules. They will also provide timely response and decisions regarding product defects based on analysis with support of manufacturing engineers and quality assurance engineers. Supports improved customer service, both internally and externally. Reviews and summarizes data, gathers information and material, and writes reports. Reviews and approves procedures and specifications.

Essential Duties & Responsibilities

• Participates with peers and subordinates in achieving objectives of quality, timely delivery of inspection, planned cost and personnel development
• Provides direct supervision and guidance to quality team
• Oversee and coordinate quality inspection activities to ensure that products meet quality requirements
• Meet corporate quality metrics and hold leads / inspectors accountable
• Maintain MFG and QA cGMP and ISO compliance
• Investigate root cause of product quality issues and administer corrective action activity to correct and prevent quality defects
• Staff and Maintain inspection personnel, which includes hiring, disciplinary action, promotions etc.
• Write, revise, review, and approve document changes
• Administrate NLR systems and procedures
• Review work order documentation for completeness and accuracy as well as disposition raw materials, components, sub-assemblies and finished product used in the manufacturing of product.
• Work on special projects as they arise

Knowledge, Skills & Qualifications

• Familiarity with cGMP, FDA, and guidelines governing the manufacture and release of medical devices.
• Familiar with ASTM and ISO 9001 Standards
• Familiarity with GD&T as well as measurement techniques using CMM or similar.
• Strong verbal and written communication skills
• Ability to supervise and manage projects and subordinates
• Excellent organizational skills
• Able to work in a fast paced environment and respond quickly to changing priorities
• Able to multitask while working on long term projects, and be able to work well under pressure

Education and Experience

• High School diploma or equivalent
• 3+ years of supervisory experience preferred
• Associates degree preferred
• Minimum 5 years of quality assurance experience in a related field, preferably medical device

Physical Requirements and Work Environment

• This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary.
• This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
• Typically requires travel less than 5% of the time

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 being an 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, 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 .... We are committed to providing equal access and opportunities for all candidates.

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