Supervisor, Quality Jobs

Title: Supervisor, Quality

Position Summary

The MQ (Manufacturing Quality) Supervisor is responsible for ensuring manufacturing operations are operating under a state of GMP compliance. Supervise the daily activities of exempt and non-exempt personnel involved in in-process monitoring, testing/sampling, quality evaluation and routine release of products manufactured at the Dublin facility. In addition, when quality-related issues arise, the incumbent will investigate, document, and lead corrective actions to assure these are managed effectively. Coordinate, develop quality system programs and projects to ensure regulatory compliance, track and manage investigations per procedures. This individual must also effectively communicate in all directions, as part of this leadership role.

Essential Duties & Responsibilities

• Supervise quality inspectors in a manufacturing environment.

• Hire, train, supervise, evaluate, and develop Quality Control employees to perform in-process monitoring of production.

• Monitor manufacturing processes and personnel to ensure compliance with Standard Operation Procedures (SOPs) and GMP requirements. Pursues resolution of issues and problems as they arise.

• Interfaces with Operations, Materials Management, Engineering, and other various departments to resolve questions and/or determine if nonconformance reports (NCMR’s) are needed. Assist in the identification and resolution of potential manufacturing problems.

• Conducts NCMR/CAPA investigations as needed.

• Update Standard Operating Procedures as necessary and to address continuous improvement opportunities.

• Provide training and conduct verification assessments to ensure adequate maintenance of quality systems and process and manage projects to ensure completion within the required time schedule as required per quality systems.

• Prepare investigation reports/data as requested.

• Review customer complaints as needed.

• Responsible for developing and executing goals and work plan for area responsibility. Maintain productivity reports.

• Ensures quality through testing and inspection at various stages of production process, and compiles and evaluates statistical data to determine and maintain quality and reliability.

• Conducts batch record reviews, author re-inspection plans, and provides quality oversight during re-inspections to assure samples are within specification limits.

• Partner with manufacturing to track and trend metrics and assist with continuous improvement.

• Perform other related duties as assigned or required.

Knowledge & Skills

• Must have working knowledge of Good Manufacturing Practices and regulatory requirements. A working knowledge of Quality tools, such as statistical quality control.

• Communication skills (both written and verbal) with all levels of management are critical to the successful performance of this position.

• Strong organizational skills and ability to write clear investigative reports.

Minimum Qualifications, Education & Experience

• Bachelor’s degree preferred or equivalent work experience.

• Minimum of 3-5 years’ experience in Quality, Manufacturing, Engineering, or R&D functions or any combination of the above, preferably in medical device, pharmaceutical, food or cosmetic industry.

Work Environment

• The MQ Supervisor role requires both manufacturing and office environment.

• This job operates in a professional office environment and routinely uses standard office equipment.

• While working in the manufacturing environment, there are high noise areas.

• Occasional lifting up to 40 lbs. unassisted.

• Typically requires travel less than 5% of the time.

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.