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SUMMARY DESCRIPTION
The Manufacturing Manager is a key member of the operations leadership team for Integra’s Collagen Manufacturing Center (CMC) in Plainsboro, NJ. This role is responsible for value stream leadership directly leading manufacturing supervisors and training, indirectly leading a cross-functional team in support of the value stream including engineering, maintenance, materials management, etc. This role is responsible for assigning and monitoring daily 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 and ISO 5 Clean Rooms and with Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOP’s), and Health and Safety requirements.
SUPERVISION RECEIVED
Under the supervision of the Director, Operations
SUPERVISION EXERCISED
Direct Management of manufacturing supervisors, who provide oversight of 1st, 2nd, and 3rd shift on-site activities, seven days a week. Must be able to work independently and with limited supervision.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Ensures through 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 employees and 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.
Leads/participates in investigative teams to resolve ongoing issues including failure investigations. Perform investigations as they pertain to the manufacturing realm of responsibilities.
Works closely with the quality department to coordinate the generation, and processing of non-conformances (NC), Corrective Preventive Action Plans (CAPA), and audit observations.
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.
Perform other related duties as required.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
Bachelor degree in Engineering, Science, Business, or equivalent with 5+ years of experience leading a team; Master degree with 2+ years of experience leading a team
Experience in the Medical Device Industry supervising manufacturing functions, including clean room environment.
Must possess strong written, verbal and interpersonal skills.
Demonstrated organizational and communication skills. Must possess strong leadership skills with team-focused attitude and approach.
Strong computer skills, including Microsoft Office experience required.
Demonstrated knowledge of FDA regulations, ISO 9001, ISO 13485, and other National and International regulations and standards.
Demonstrated computer skills. Must be capable of working in an Oracle Enterprise Resource Planning (ERP) system. Database and quality data reporting experience required. Understanding of basic MRP process to control and complete work orders necessary.
Must be able to gown into ISO 7 and ISO 5 Clean Room gowning.
Batch manufacturing experience.
Understanding of Lean/six Sigma a plus.
Experience working in a chemical environment with a thorough understanding of the safety applications is required.
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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