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About the Role
The MQ (Manufacturing Quality) Supervisor ensures manufacturing operations comply with GMP standards. This role supervises daily activities of personnel involved in in-process monitoring, testing, quality evaluation, and product release. The supervisor investigates quality-related issues, leads corrective actions, and develops quality system programs to ensure regulatory compliance.
Responsibilities
- Supervise quality engineers and inspectors in a manufacturing environment.
- Provide supervision during the absence of the MQ Section Manager and during off shifts.
- Hire, train, supervise, evaluate, and develop MQ employees.
- Monitor manufacturing processes and personnel for compliance with SOPs and GMP requirements.
- Resolve issues and problems as they arise.
- Interface with Operations, Materials Management, Engineering, and other departments to resolve questions and determine if exception reports are needed.
- Assist in the identification and resolution of potential manufacturing problems.
- Conduct ER/CAPA investigations.
- Update Standard Operating Procedures as necessary.
- Provide training and conduct verification assessments to ensure adequate maintenance of quality systems and processes.
- Manage projects to ensure completion within the required time schedule.
- Prepare investigation reports/data as requested.
- Develop and execute goals and work plan for area responsibility.
- Maintain productivity reports.
- Ensure quality through testing and inspection at various stages of the production process.
- Compile and evaluate statistical data to determine and maintain quality and reliability.
- Conduct batch record reviews.
- Author re-inspection plans.
- Provide quality oversight during re-inspections to assure samples are within specification limits.
- Partner with manufacturing to track and trend metrics.
- Assist with continuous improvement.
- Perform other related duties as assigned or required.
Requirements
- Must be at least 18 years of age.
- Minimum of 2 years’ experience in Quality, Manufacturing, Engineering, or R&D functions or any combination of the above, preferably in pharmaceutical, food or cosmetic industry is required.
Skills
- Knowledge of parenteral manufacturing preferred.
- Working knowledge of Good Manufacturing Practices and regulatory requirements.
- Working knowledge of Quality tools, such as statistical quality control.
- Strong written and verbal communication skills with all levels of management.
- Strong organizational skills.
- Ability to write clear investigative reports.
Location
- Austin facility
Work Type
- 3rd shift: Wednesday - Friday and every other Saturday (6:00pm - 6:00am)
- Manufacturing environment
- Office environment
Experience Level
- Minimum of 2 years’ experience
Education Level
- Bachelor’s degree from an accredited college or university is required: Chemistry, Engineering, Biology, or Microbiology degree preferred.
About the Company
- We manufacture the critical IV solutions providers count on to deliver consistent, reliable care.
- Each product we make helps ensure patients receive the therapies they need without disruption.
- When you work here, you become part of something bigger—a team dedicated to reliability and innovation.
- No matter the role, your work directly strengthens the healthcare supply chain and impacts patients nationwide.
- We offer opportunities for growth, collaboration, and meaningful contributions, all in pursuit of a mission that truly matters.
- Join us and help shape the future of IV solutions.
Equal Opportunity
- Otsuka 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 austinhr@icumed.com.
- We are committed to providing equal access and opportunities for all candidates.