Description
Job Title
Quality Supervisor
FLSA Status
Exempt
Shift
(4:00 pm to 1:00 am)
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. Maintains and ensures 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. Monitors QA personnel inspection performance and provides appropriate coaching, training, or disciplinary feedback as necessary.
Essential Duties & Responsibilities
• 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
• 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
Minimum Qualifications, Education & Experience
• Bachelor's degree from an accredited college or university
• Minimum 5 years of quality assurance experience in a related field
Work Environment
• Typically requires travel less than 5% of the time.
• 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.
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.
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