Director of Production Medical Devices Job Listing at Fresenius Medical Care in Walnut Creek, CA

Healthcare

PURPOSE AND SCOPE:
Support FMCNA’s vision, mission, core values and customer service philosophy. Adheres to and supports the organization’s compliance program, including all regulatory and division/company policy requirements.

Establish, implement, maintain and manage all objectives, requirements, standards, practices and procedures of the Manufacturing Facility. Establishes and manages production systems, quality standards, safety standards, personnel systems, financial system, and other facility administrative systems.

DUTIES / ACTIVITIES:

CUSTOMER SERVICE:

• Responsible for driving the FMCNA culture through values and customer service standards.


• Accountable for outstanding customer service to all external and internal customers.


• Develops and maintains effective relationships through effective and timely communication.


• Takes initiative and action to respond, resolve and follow up regarding customer service issues with all customers in a timely manner.

PRINCIPAL RESPONSIBILITIES AND DUTIES:

• Collaborates with Research and Development functions to transfer new technology into manufacturing.


• Forms and directs cross-functional teams for product transfer resulting from acquisitions and mergers, directing manufacturing operations in the introduction of new or enhanced products, processes and systems.


• Opens and sustains communication with sales and marketing arms to coordinate manufacturing goals to sales strategies and forecasts.


• Ensures the highest level of product quality, compliance to product specifications and fulfillment of customer demand by analyzing work practices, standard operating procedures and systems for optimized and efficient work flow.


• Implements and reviews key performance indicators for quality, production yield, cost containment and resource optimization


• Ensures budgets, production and financial goals are established and communicated to manufacturing management, including cost standards and cost reduction projects.


• Provides oversight in the qualification, verification or validation of test equipment, fixtures and other manufacturing systems.


• Collaborates closely with various departments: (1) Quality Systems to ensure quality standards, compliance/ regulatory requirements, and achievement quality goals. (2) IMPAQ Office to implement and sustain continuous improvement through application of lean six sigma principles and practices. (3) Materials Management for timely procurement of raw materials, customer spare parts, technical service and new product development. (4) Human Resources to ensure compliance with employee recruitment, overtime and disciplinary processes.


• Comply with the code of business conduct and all relevant company policies, procedures, and local, state, and federal laws/regulations.


• Other duties and projects as assigned from time to time.

EDUCATION:

B.S./B.A. degree with 7 to 10 years technical/manufacturing experience. A master’s degree is a plus.
EXPERIENCE AND REQUIRED SKILLS:

• 7 to 10 years experience in progressively responsible management positions in a device manufacturing industry


• Experience with personnel management, quality, budget planning, general finance, material management and resource planning.


• Good familiarity with FDA, GMP, OSHA, EPA or ISO regulatory requirements.

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