Quality Control Supervisor

Job Description:

Ohio Medical is a global leader in medical air and vacuum pumping systems, suction, and oxygen therapy devices. Our trusted brands, including Ohio Medical and Amvex, offer cutting-edge solutions such as suction regulators, air and oxygen flow meters, pumping systems, and portable suction equipment. Operating in an FDA-regulated facility, we adhere to ISO 13485, ISO 9001, and NFPA 99 standards, ensuring high-quality and reliable products that meet global regulatory requirements. Headquartered in Gurnee, IL, we take pride in our commitment to patient safety, innovation, and quality products.

With a history dating back over 100 years, Ohio Medical has shaped the medical industry. In 1910, we manufactured one of the first anesthesia gas machines, The Ohio Monovalve, which was extensively used during World War I. Our legacy includes innovations such as the Push-To-Set (PTS) suction regulator and advancements in medical gas and oxygen therapy. In 2022, Ohio Medical joined The ESAB Corporation, furthering our mission to deliver innovative, high-quality products that prioritize patient safety. Join a team where history meets innovation and make an impact on the future of healthcare.

Your Opportunity:

The Quality Control Supervisor will manage directly and closely support the quality inspectors in all areas and will assist the QC Manager to build up a team of competent QC inspectors to achieve consistent compliance, timely and safe execution of tasks. The Quality Control Supervisor will monitor and control the daily activities of quality inspection, testing, and documentation review. Carry out QC tasks/ inspections when required, to support the team. The Quality Control Supervisor is responsible for leading the team in becoming examples for the business by adherence to all aspects of the Quality Management System while ensuring that internal and external customer needs are met.

• Supervise shift personnel in the quality control department consistent with high safety and quality standards.

• Troubleshoot problems arising on the shop floor in conjunction with quality standards with the appropriate engineering support from Quality Engineering functions

• Maintain close observation of quality requirements to keep quality management informed of status and, when needed, initiate the necessary steps to conform to schedule / staffing requirements.

• Promote and support site initiatives including quality safety programs, lean initiatives, training programs, and consistently interpret and apply all policies, practices and procedures among plant team members.

• Recommend and implement measures to motivate team members and to encourage employees to recommend ways to improve process, quality, safety and efficiency.

• Routinely evaluate team member performance and identify training needs.

• Coach and counsel team members for performance, attendance and behavior. Participate in the resolution of team members relations issues.

• Review and approve work time in the appropriate timekeeping system.

• Maintain and verify accuracy of the hours each team member has worked.

• Works independently to identify Quality issues, initiate nonconformance reports, and recommend corrective actions

• Determine product acceptability by performing various types of inspections and measurements utilizing varying laboratory equipment and taking care of valid calibration (internal and external)

• Create, utilize, and maintain testing result forms

• Develop sampling plans and activities, as required

• Authoring of quality notifications such as deviations and OOS ( visual and dimensional)

• Support review of batch production records and perform review, approval, and release of product and materials within the inventory management/ERP system

• Ensures compliance with quality system documents, cGMPs, ISO standards and FDA regulations.

• Work with technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence.

• Manage the team's performance, conduct performance 1 to 1's, support recruitment, training and development plans while addressing any issues that arise in a timely manner

• Liaise with internal and external customers and other departments as appropriate.

• Ensure that the QC inspection conducted are performed according to relevant procedures and data reported in compliance with data integrity principles

• Act as a central point of communication for all departments in respect to product quality issues on the shop floor and ensure that these are escaladed appropriately.

• Other duties as assigned Additional Responsibilities:

• Participate in special project teams as assigned.

• Performs other duties as assigned based on business needs.

• Conforms with and abides by all laws, regulations, safety rules, policies, and work procedures, and all instructions.

• Exhibits regular, reliable, punctual and predictable attendance

• Quality Assurance/ Continuous Improvement

• Key stakeholder in the risk management process, specifically process risk and job hazards

• Application of Six Sigma methodologies such as process mapping, (P)FMEA, Gage R&R

• Responsible for failure investigation, determination of root cause and CAPA implementation

• Minimum of 5+ years of progressive Quality experience in various sized medical device organizations

• Minimum 2 years Management experience with direct reports

• Knowledge of ISO 13485 and FDA cGMPs

• Bachelor's Degree Required (Life Sciences, Engineering or Business)

• Master's Degree a plus

• English and Spanish required

• Excellent communication skills, both verbal and written, and the ability to interface effectively with internal departments; engineering, manufacturing, sales and marketing, administration and external customers and suppliers

• A "hands-on" highly accountable individual who enjoys challenge and is capable and dedicated to getting the job done

• A proactive, results driven leader with a positive "can do" attitude and a sense of urgency to getting things done

• Well-organized, detail oriented and accustomed to maintaining excellent records

This job description in no way states or implies that these are the only duties to be performed by this employee. The incumbent is expected to perform other duties necessary for the effective operation of the department or unit. This job description may be changed at any time. Ohio Medical is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.

• View our benefits: Ohio Medical

Pay Range: