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The Supervisor, Automated Medical Operations is responsible for the medical dispersion production activities for CMC (Collagen Manufacturing Center) to ensure the safety, efficacy, and quality of our medical devices. This includes assigning and monitoring daily first shift activities of production staff and partnering with other support departments to efficiently and compliantly complete work and work processes as per outlined production schedules. All production is to be conducted in compliance with ISO 7 Clean Rooms and with Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOP’s), and Health and Safety requirements. This job is expected to work onsite.

SUPERVISION EXERCISED

Directly supervises first shift manufacturing cleanroom operators and lead operators.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• Ensures thorough behavior and action a safe working environment for all employees.

• Facilitates teamwork and cooperation with a focus on developing a Lean culture, with the ultimate goal of a high level of employee engagement and customer satisfaction.

• Ensures all established costs, quality, and delivery commitments are met, working within FDA medical device regulations, and applicable ISO standards.

• Responsible for the overall direction, coordination, and evaluation of the manufacturing area, overseeing all production activities to ensure that all Standard Operating Procedures (SOPs) are properly followed.

• Provides daily coaching and development to their direct reports.

• Reviews production and operating reports and participates in the resolution of operational, manufacturing, and maintenance problems to ensure minimum costs, prevent operational delays, and maintain quality and regulatory compliance standards.

• Trains and ensures all assigned employees are aware of and comply with company, government procedures, and regulations.

• Partners with other functions such as Facilities, Maintenance, Engineering, Quality, Warehouse, and Planning groups to ensure a seamless flow of activities across and during the shift.

• Participates in investigative teams to resolve ongoing issues including failure investigations. Perform investigations as they pertain to the manufacturing realm of responsibilities.

• Reports any non-conformances in a timely manner.

• Works closely with the quality department to coordinate the generation, and processing of non-conformances (NC), Corrective Preventive Action Plans (CAPA), and audit observations in a timely manner.

• Pass and maintain gowning qualification for ISO 5 and ISO 7 Clean rooms.

• Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance and managing employee performance, addressing complaints, and resolving problems.

• May also perform other related duties, responsibilities, and special projects as assigned.

DESIRED MINIMUM QUALIFICATIONS

• Bachelor’s degree or higher in Science, Engineering, or related fields is desired.

• 3+ years of relevant leadership experience in a GMP regulated industry.

• Knowledge of NCs and CAPAs.

• Must have strong written and verbal communication skills. Must possess strong leadership skills with team-focused attitude and approach.

• Must be able to gown into ISO 7 and ISO 5 Clean Room gowning.

• Batch manufacturing experience.

• Demonstrated knowledge of FDA regulations, ISO 9001, ISO 13485, and other National and International regulations and standards.

• Strong computer skills, including Microsoft Office experience required.

• Automation experience a preferred.

• Knowledge of Oracle R12/Agile preferred.

• Understanding of Lean/six Sigma a plus.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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