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This job description is designed to outline the primary functions and qualifications of this position. This definition does not limit the employee or Integra to just the areas described. It does not identify all tasks that may be required or address performance exceptions, nor does it limit Integra from changing the content. The job description does not constitute an employment agreement between the employer and employee.

The incumbent is responsible for directing, supervising, and coordinating activities of workers of the production department engaged in assembly and manufacturing of medical devices. Plans production operations for existing product lines for manufacturing activities to ensure production and quality of products meet deadlines and specifications.

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

This process supervises upstream operations including Collagen dispersion, and Lyophilization as well as downstream including inspection, cutting, sealing and packaging.

Supervises and directs Supervisors, Cell Leaders, Group Leaders, Machine Operators, Assemblers, and other employees engaged in production operations to the assigned department.

Receives production orders or schedules to ascertain product data, such as types, quantities, and specifications of products and scheduled delivery dates in order to plan department operations.

Plans production operations, establishing priorities and sequences for manufacturing products, utilizing knowledge of production processes and methods, machine and equipment capabilities and human resource requirements.

Prepares operational schedules and coordinates manufacturing activities to ensure production and quality of products meets specifications.

Receives production and operating reports and resolves operational, manufacturing, and maintenance problems to ensure minimum costs and prevent operational delays.

Evaluates employee's performance on a timely basis and recommends personnel actions, such as promotions, transfer, discharge, or disciplinary measures.

Inspects machines and equipment to ensure specific operational performance and optimum utilization.

Develops or revises standard operational and working practices and observes working to ensure compliance with standards.

Trains employees in work methods and procedures and encourages employees accomplishment of other work skills and career development.

Prepares and maintains clear and accurate documents and department records to provide back- up information for management decision making and to comply with GMP and company policies.

Informs and maintenance constant communication with supervisory and management personnel concerning quality issues related to manufacturing operations, deviations occurring from existing standards, deficiencies and accomplish cost reductions and company goals.

Encourages workers support to the department efficiency and accomplishment of production plan and company goals.

Resolve worker grievances or submit unsettled grievances to management staff for action.

Fully responsible for end-to-end manufacturing.

MINIMUM QUALIFICATIONS - Education and Experience

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• Bachelor's degree in Sciences, Business Administration, or Engineering.

• 8 to 10 years supervisory experience in a manufacturing environment, in an FDA regulated environment preferred A minimum of two years supervisory/coordination experience in Manufacturing areas in an FDA regulated environment preferred

• Strong knowledge of GMP's, Manual Assembly, Packing Operations, and OSHA regulations.

• Strong interpersonal and communication skills.

• Ability to supervise employees in medical device manufacturing operations

• Fully Bilingual

ADVERSE WORKING CONDITIONS

The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position, which is that of a general plant environment.

Ensures workers adherence to GMP, company policies, safety practices, and Clean Room Rules, and Gowning Practices.

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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EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)

Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.

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