Director Rc/Qa

The Cooper Companies Rochester , NY 14618

Posted 3 months ago

CooperVision, a unit of The Cooper Companies, Inc. (NYSE:COO), is one of the world's leading manufacturers of soft contact lenses and related products and services. The Company produces a full array of monthly, two-week and 1-day lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism and presbyopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com.

JOB TITLE: Director RC/QA

DEPARTMENT: RC/QA

JOB SUMMARY

Directs and oversees the Quality Assurance and Regulatory Compliance functions in order to assure that quality as well as local and external regulatory requirements are met.

ESSENTIAL FUNCTIONS

  • Responsible for the Quality Assurance and Regulatory Compliance functions for the Scottsville facility.

  • Ensures the promotion of awareness of applicable regulatory requirements and Quality Management system requirements throughout the organization.

  • Ensures that the processes needed for the Quality Management System are established, implemented and maintained.

  • Contributes to the achievement of company objectives by playing an active role (Steering Committee) in the strategic planning process including the development of quality targets and long range strategic plans (LRSP) for continuous quality improvement.

  • Defines quality objectives and functional responsibilities.

  • Monitors progress of the Quality KPI's in achieving the Quality LRSP and communicate it to the organization and senior management.

  • Interfaces with the manufacturing organization to analyze the effectiveness of the Quality Management System (eQMS).

  • Ensures that the performance of the Quality Management System including performance against quality policy objectives is reported to senior management including any areas of improvement.

  • Determines and enforces through functional groups quality requirements in accordance with current regulations and customer requirements.

  • Contributes to the quality improvement efforts of the company by following a structured continuous improvement approach, and focusing on root cause identification and correction.

  • Integrates quality and regulatory planning, in collaboration with Global Regulatory, with the planning for new or modified materials, products, components, equipment, and processes.

  • Oversees FDA and ISO inspections and any external audits/assessments to ensure that the facility Quality Management System is properly represented.

  • Serves as the facility Management Representative.

  • Serves as the Scottsville Recall Coordinator and executes recall reporting to FDA.

  • Represents the facility in the World-Wide Quality Assurance team (WWQA) and supports the corporate/legal RA/QA functions.

  • Serves as a facilitator and mentor to subordinators and fellow co-workers.

  • Responsible for overall staffing, planning, training, and employee relations to achieve departmental objectives and key performance indicators, while following SOP and ISO requirements. As required hires, terminates, evaluates and disciplines employees in accordance with current personnel policies, including performance management and performance improvement plans. Regularly leads and monitors employee's performance to assure that departmental goals and objectives are met. Ensures that staff is adequately trained and responsive to end user needs.

CooperVision's management team is committed to the development of and implementation of the quality management system and maintaining its effectiveness by communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements.

POSITION QUALIFICATIONS

KNOWLEDGE, SKILLS AND ABILITIES

  • Experience working in a team environment, and proven ability to provide guidance that will promote good communications, objective thinking, and cooperation among different teams

  • Proven ability to effectively contribute to the quality improvement efforts of the company

  • Proven experience in establishing procedures for maintaining high standards of product quality and reliability

  • Strong knowledge of FDA and international regulations

  • Extensive experience in the regulatory compliance area

  • Experience as lead contact point for regulatory agencies within a manufacturing operation

  • Solid knowledge of Microsoft Office Suite

WORK ENVIRONMENT

  • Normal office environment

  • Exposure to manufacturing Manufacturing/Distribution environment

  • Extended periods of sitting and using a computer.

  • Travel may be required (generally 10% domestic/10% international)

EDUCATION

  • Bachelors' Degree preferable in Science or Engineering; or an equivalent combination of education and experience.

EXPERIENCE

  • A minimum of 8-10 years of relevant professional experience in the medical device or pharmaceutical industry, preferably in a Manufacturing/Distribution environment.

CooperVision, Inc. is an EEO/AA Employer M/F/D/V

'231562


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Director Rc/Qa

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