Supervisor, Quality

ICU Medical; Salt Lake City (UT); On-site; USD 60,000 - 65,000; Full time

Job summary

ICU Medical is seeking a Supervisor for Quality Systems in Salt Lake City. This key role focuses on managing quality audits and compliance to ensure adherence to cGMP and maintaining a strong quality culture. Candidates should have a strong background in quality assurance with significant experience in regulated industries.

Qualifications

• Minimum of five years of experience in quality systems.
• 2-4 years of management experience preferred.
• Experience in medical device manufacturing environment is a plus.

Responsibilities

• Manage internal quality audit program for compliance.
• Oversee nonconformance processes and ensure timely resolutions.
• Lead training on compliance and cGMP regulations.

Skills

Strong verbal and written communication skills

Ability to supervise and manage projects

Knowledge of ISO 13485

Education

Bachelor’s degree in sciences or technical

Tools

Microsoft Excel

Microsoft Word

PowerPoint

Job description

Join to apply for the Supervisor, Quality role at ICU Medical

3 days ago Be among the first 25 applicants

Join to apply for the Supervisor, Quality role at ICU Medical

Get AI-powered advice on this job and more exclusive features.

JOB DESCRIPTION

The Quality Systems Supervisor is responsible for managing internal quality audit program and all readiness activities to support, host and respond to external regulatory and customers audits for the Salt Lake City Facility. This role will support development and implementation of processes and systems that enhance compliance to Current Good Manufacturing Practice (cGMP) and an adequate quality culture within the facility and serves as a liaison between the manufacturing plant and other company functions regarding general regulatory compliance requests from agencies and customers. Collaborate with other internal and external quality, operation and technical functions to lead and support initiatives around improving overall QMS compliance. Supervises personnel handling Document Control, Final Quality Audits to manufacturing records prior to release product and Quality Data Analysts. Assist, train and coach different plant teams around QMS audits and general compliance to Quality System Regulations and Standards for Medical Devices and frequent monitoring of quality system indicators and metrics.

• Audit Programs Administration. Plan, conduct and management internal audit program for the site to ensure compliance with internal procedure and regulatory requirements. Collaborate with multidisciplinary teams for timely corrective actions to address non-compliances found during this process and compliance to internal and external procedures.
• Able to lead internal audits and to act as the face during customer audits for the facility
• Ensure external audits/inspection are properly hosted and develop and maintain appropriate readiness activities for the site. Collaborate with Site Quality Leader other functional areas on the response to any observation or inquiry resulting from these activities. Properly communicate with site functional leaders and peers about external audits/inspection readiness plans and site compliance status. Must be knowledge, resourceful, innovative and diplomatic in resolving and preventing quality problems encountered.
• Oversees and handle QMS nonconformance process for the site, ensuring a timely resolution and track and trending in compliance with procedure.
• Plan and administrate cGMP audit program into different key processes to monitor overall alignment to procedure and standards.
• Must be able to review and recommend document and process changes based on the identification of potential problems with specification, methods, procedures or systems. Should track such changes and improvements make.
• Conducts cGMP, Site Readiness, audits techniques and other compliance training for plant employees to assure employee awareness of their responsibility to cGMP compliance and continue preparation for regulatory audits.
• Handle inquires coming from Global Regulatory functions, customers and/or regulators related to the site manufactured products or processes. Responsible to receive, reviews, track, distributes to appropriate function, respond and controls these inquires to ensure a timely and accurate response is provided.
• Collect and analyze quality trend data that could potentially impact compliance aspects and product quality. Monitor Key Performance Indicators (KPI) to assess performance of QMS Nonconformances, Audits and cGMP compliance for the facility. Able to highlight trends, risks and opportunities for improvement and to drive resolution.
• Recruit, train, lead, retain and mentor direct reports and able to identify and implement changes to existing organization structure to better support the activities within the organization.
  
  

Position Summary

JOB DESCRIPTION

The Quality Systems Supervisor is responsible for managing internal quality audit program and all readiness activities to support, host and respond to external regulatory and customers audits for the Salt Lake City Facility. This role will support development and implementation of processes and systems that enhance compliance to Current Good Manufacturing Practice (cGMP) and an adequate quality culture within the facility and serves as a liaison between the manufacturing plant and other company functions regarding general regulatory compliance requests from agencies and customers. Collaborate with other internal and external quality, operation and technical functions to lead and support initiatives around improving overall QMS compliance. Supervises personnel handling Document Control, Final Quality Audits to manufacturing records prior to release product and Quality Data Analysts. Assist, train and coach different plant teams around QMS audits and general compliance to Quality System Regulations and Standards for Medical Devices and frequent monitoring of quality system indicators and metrics.

Essential Duties & Responsibilities

• Audit Programs Administration. Plan, conduct and management internal audit program for the site to ensure compliance with internal procedure and regulatory requirements. Collaborate with multidisciplinary teams for timely corrective actions to address non-compliances found during this process and compliance to internal and external procedures.
• Able to lead internal audits and to act as the face during customer audits for the facility
• Ensure external audits/inspection are properly hosted and develop and maintain appropriate readiness activities for the site. Collaborate with Site Quality Leader other functional areas on the response to any observation or inquiry resulting from these activities. Properly communicate with site functional leaders and peers about external audits/inspection readiness plans and site compliance status. Must be knowledge, resourceful, innovative and diplomatic in resolving and preventing quality problems encountered.
• Oversees and handle QMS nonconformance process for the site, ensuring a timely resolution and track and trending in compliance with procedure.
• Plan and administrate cGMP audit program into different key processes to monitor overall alignment to procedure and standards.
• Must be able to review and recommend document and process changes based on the identification of potential problems with specification, methods, procedures or systems. Should track such changes and improvements make.
• Conducts cGMP, Site Readiness, audits techniques and other compliance training for plant employees to assure employee awareness of their responsibility to cGMP compliance and continue preparation for regulatory audits.
• Handle inquires coming from Global Regulatory functions, customers and/or regulators related to the site manufactured products or processes. Responsible to receive, reviews, track, distributes to appropriate function, respond and controls these inquires to ensure a timely and accurate response is provided.
• Collect and analyze quality trend data that could potentially impact compliance aspects and product quality. Monitor Key Performance Indicators (KPI) to assess performance of QMS Nonconformances, Audits and cGMP compliance for the facility. Able to highlight trends, risks and opportunities for improvement and to drive resolution.
• Recruit, train, lead, retain and mentor direct reports and able to identify and implement changes to existing organization structure to better support the activities within the organization.
  
  

Knowledge, Skills

• Strong knowledge of ISO 13485, FDA regulations, and medical device quality standards.
• Experience in leading audits. Certified Quality Auditor desirable.
• Strong verbal and written communication skills and training skills
• Ability to supervise and manage projects and subordinates
• Ability to interact with customers and regulatory agencies professionally
• 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
• Must be able to perform duties and responsibilities assigned with minimal supervision.
  
  

Education And Experience

• Bachelor’s degree in sciences or technical are required.
• Minimum of five years of experience in quality systems, audits and regulatory compliance for regulated industry.
• 2-4 years of management experience
• Prior experience in medical device manufacturing environment coupled with certifications from ASQ preferred.
• Must be proficient using 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 5-10% 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 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 [e-mail]. We are committed to providing equal access and opportunities for all candidates.

ICU Medical EEO Policy Statement

Know Your Rights: Workplace Discrimination is Illegal Poster

ICU Medical CCPA Notice to Job Applicants

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

Referrals increase your chances of interviewing at ICU Medical by 2x

Sign in to set job alerts for “Quality Supervisor” roles.

Certified Quality Auditor @ Salt Lake City, Utah (1099 Contractor)

Quality Control Supervisor - Nutrient Ingredient Manufacturing

Salt Lake City, UT $60,000.00-$65,000.00 1 week ago

Salt Lake City Metropolitan Area 3 weeks ago

Salt Lake City Metropolitan Area $70,000.00-$90,000.00 2 weeks ago

Second Shift Supervisor II, Manufacturing

Salt Lake City, UT $50,000.00-$65,000.00 3 months ago

Salt Lake City Metropolitan Area 1 week ago

Salt Lake City Metropolitan Area $125,000.00-$145,000.00 4 days ago

Salt Lake City, UT $20.00-$26.00 4 days ago

Swing Shift Production Supervisor 4:30 pm to 3:00 am

Swing Shift Production Supervisor 4:30 pm to 3:00 am

Industrial Water Treatment Operations & Maintenance (O&M) Regional Supervisor – U.S. Western Region

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.