ICU Medical
Overview
Join to apply for the
Manager, Engineering - Quality
role at
ICU Medical . This role is responsible for coordinating and managing a quality engineering team focused on hands-on quality support for prevention and/or early detection of product quality events, ensuring proper evaluation and resolution while maintaining regulatory compliance and procedures. Responsibilities
Lead and coach the Manufacturing Quality Engineers and ensure an appropriate quality engineering structure to meet quality expectations and business needs to support the product lifecycle. Implement quality engineering tools in operations to drive methodical, process-based improvements. Utilize Six Sigma, Lean, advanced statistics, and other proven tools as appropriate. Collaborate with Engineering, Maintenance, Production, Quality Operations and other functions to promptly resolve and prioritize quality problems for products and processes, driving high-quality results. Oversee, document, and approve nonconformances (product and non-product related) in a timely manner; mentor in problem solving and root cause analysis. Proactively drive continuous improvement activities to prevent problems and resolve issues efficiently and cost-effectively. Review and approve documentation including Nonconformances, CAPAs, and QMS procedures. Conduct GMP training for plant employees to ensure awareness of GMP compliance. Assist with Customer, FDA and other regulatory inspections as needed. Recruit, train, lead and mentor direct reports; collaborate with the Site Quality Leader on goals, budgets and plans for utilizing Quality Organization resources. Optimize inspection methods and sampling; work effectively in a team with shifting priorities and time-sensitive requirements. Perform other functions as necessary or assigned, including special projects. Qualifications
Practical knowledge of Nonconformance, CAPA, Complaints and/or Supplier Quality Processes for regulated industry. Strong leadership, negotiation, and collaborative skills; ability to influence across the organization. Ability to work with urgency in a fast-paced environment; strong analytical, problem-solving and decision-making skills. Ability to set priorities, complete projects with minimal supervision, and manage multiple tasks. Excellent organizational and time-management skills with attention to detail; strong presentation and communication skills to interface with multiple departments and sites. Experience with Quality Sciences (Acceptance Sampling, SPC, Six Sigma, Lean, DOE, COQ, Cause & Effect analysis, etc.). Experience writing, reviewing, and approving quality documents. Knowledge of national and international regulations applicable to medical devices (Quality System Regulations, 21 CFR 820, Canadian MDR, ISO 14971, ISO 13485). Proficiency in Minitab or similar statistical software and MS Office. Education And Experience
Bachelor’s degree in sciences or technical area required. Minimum 8 years of related experience; 2-4 years of management experience. Prior experience in a medical device manufacturing environment; ASQ certifications preferred. Must be proficient in Minitab or statistical software, Microsoft Excel, Word, PowerPoint, and Outlook. Physical Requirements And Work Environment
Regularly able to talk or hear; this role operates mainly in an office environment and controlled manufacturing areas requiring gowning. Computer work for extended periods; ability to stand and walk as needed. Typically requires travel 10-20% of the time. About Us
ICU Medical provides clinical innovations to solve real-world challenges. Following acquisitions, we are a global leader with a full line of IV therapy and critical care products for hospital, alternate site, and home care settings. We focus on quality, innovation and value across our offerings and operations, with a commitment to equal opportunity employment. Contact and Equal Opportunity
ICU Medical is an Equal Opportunity Employer. Qualified applicants receive fair consideration without regard to 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 need reasonable accommodation during the employment selection process, please contact humanresources@icumed.com.
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Join to apply for the
Manager, Engineering - Quality
role at
ICU Medical . This role is responsible for coordinating and managing a quality engineering team focused on hands-on quality support for prevention and/or early detection of product quality events, ensuring proper evaluation and resolution while maintaining regulatory compliance and procedures. Responsibilities
Lead and coach the Manufacturing Quality Engineers and ensure an appropriate quality engineering structure to meet quality expectations and business needs to support the product lifecycle. Implement quality engineering tools in operations to drive methodical, process-based improvements. Utilize Six Sigma, Lean, advanced statistics, and other proven tools as appropriate. Collaborate with Engineering, Maintenance, Production, Quality Operations and other functions to promptly resolve and prioritize quality problems for products and processes, driving high-quality results. Oversee, document, and approve nonconformances (product and non-product related) in a timely manner; mentor in problem solving and root cause analysis. Proactively drive continuous improvement activities to prevent problems and resolve issues efficiently and cost-effectively. Review and approve documentation including Nonconformances, CAPAs, and QMS procedures. Conduct GMP training for plant employees to ensure awareness of GMP compliance. Assist with Customer, FDA and other regulatory inspections as needed. Recruit, train, lead and mentor direct reports; collaborate with the Site Quality Leader on goals, budgets and plans for utilizing Quality Organization resources. Optimize inspection methods and sampling; work effectively in a team with shifting priorities and time-sensitive requirements. Perform other functions as necessary or assigned, including special projects. Qualifications
Practical knowledge of Nonconformance, CAPA, Complaints and/or Supplier Quality Processes for regulated industry. Strong leadership, negotiation, and collaborative skills; ability to influence across the organization. Ability to work with urgency in a fast-paced environment; strong analytical, problem-solving and decision-making skills. Ability to set priorities, complete projects with minimal supervision, and manage multiple tasks. Excellent organizational and time-management skills with attention to detail; strong presentation and communication skills to interface with multiple departments and sites. Experience with Quality Sciences (Acceptance Sampling, SPC, Six Sigma, Lean, DOE, COQ, Cause & Effect analysis, etc.). Experience writing, reviewing, and approving quality documents. Knowledge of national and international regulations applicable to medical devices (Quality System Regulations, 21 CFR 820, Canadian MDR, ISO 14971, ISO 13485). Proficiency in Minitab or similar statistical software and MS Office. Education And Experience
Bachelor’s degree in sciences or technical area required. Minimum 8 years of related experience; 2-4 years of management experience. Prior experience in a medical device manufacturing environment; ASQ certifications preferred. Must be proficient in Minitab or statistical software, Microsoft Excel, Word, PowerPoint, and Outlook. Physical Requirements And Work Environment
Regularly able to talk or hear; this role operates mainly in an office environment and controlled manufacturing areas requiring gowning. Computer work for extended periods; ability to stand and walk as needed. Typically requires travel 10-20% of the time. About Us
ICU Medical provides clinical innovations to solve real-world challenges. Following acquisitions, we are a global leader with a full line of IV therapy and critical care products for hospital, alternate site, and home care settings. We focus on quality, innovation and value across our offerings and operations, with a commitment to equal opportunity employment. Contact and Equal Opportunity
ICU Medical is an Equal Opportunity Employer. Qualified applicants receive fair consideration without regard to 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 need reasonable accommodation during the employment selection process, please contact humanresources@icumed.com.
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