Quality Manager - Rockport, MA

Company:

Small medical device manufacturer of LIM/LSR injection molded products. Reports directly to the VP/Gen Mgr as the Management Representative and has overall responsibility for all aspects of the quality management system and quality control areas. Also reports on dotted line to Corp Dir of QA.

Duties:

• Manages the day to day and long term activities of the quality department.
• Coordinate FDA regulations. Coordinate ISO 9001 & implement ISO13485 systems.
• Interfaces with customers and suppliers about problems and establishing standards.
• Prepares reports required for the Management Review Meetings.
• Is responsible for monthly metrics on delivery performance and customer complaints.
• Reviews and approves all quality system and manufacturing related documents.
• In conjunction with the Office Manager, is responsible for having contract reviews performed for all customer purchase orders.
• Prepares, completes and publishes the Internal Audit schedules and ensuring they are accurate.
• Performs quality planning for incoming, in-process and final acceptance using customers' requirements (if available).
• Overall responsibility for the corrective and preventive action programs, calibration/metrology program and control of documents.

• 4 year degree-BS/BA.
• Must have 5-10 or more years experience in managing quality assurance and quality control departments in a medical products or thermoplastic products manufacturing facility.
• Must have a background in quality management systems with FDA & ISO standards:
• a. ISO ISO 13485:2003 - Quality Systems - Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes.
• b. ISO 14969:2004 - Medical Devices - Quality Management Systems-Guidance on the application of ISO 13485:2003
• c. ISO 14971:2000-and 1; 2003; Medical Devices - Application of Risk Management to Medical Devices.
• Excellent verbal, written, organizational and planning skills.
• Ability to lead training requirements.

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