Quality Manager

Supervise and manage the development and maintenance of all plant quality systems including supplier development, calibration, internal auditing, CAPA, quality engineering, production support efforts including validation/testing in the Jaffrey, NH facility. Manage OEM complaint handling. Establish and implement compliance training programs. Ensure that necessary regulatory corporate compliance systems are in place and adhered to. Represent quality for new product development and provide statistical support as needed throughout the plant. This position serves as the Management Representative for the Jaffrey, NH facility. Position is based in Jaffrey, NH.

Principal Responsibilities

Management and development of staff in the facilitiy; ensures that CAPA, supplier/internal audits, calibration system, supplier development engineering, quality engineering, and complaint handling are staffed with qualified employees; ensure that direct reports are appropriately trained and have resources to do their assigned tasks; provide reports with career development opportunity
• Develop quality systems and establish procedures in compliance to FDA regulations and ISO requirements
• Work on assigned projects with limited supervision
• Represent Quality for new and existing product improvement, manufacturing transfers, and quality plan initiatives. Support protocol, procedure and specification development
• Complete special assignments as assigned by the Director of QARA
• Generally operate with appreciable latitude for actions or decisions on day-to-day activities; receive guidance on novel or controversial problems
• Outline and implement improvements to Quality System, and processes 

Education / Experience Requirements

• B.S. Degree in Engineering, Physical Science or similar. Masters Degree preferred.
• Minimum of 5 years medical device industry experience
• Minimum of 5 years related quality experience in a manufacturing environment
• Minimum of3 years experience supervisory or management experience 
• ASQ CQA or CQE certification preferred
• Broad engineering experience in manufacturing operations including new product development, cost reduction, and quality engineering
• Knowledge in textiles, clean room controls, medical device development and device assembly desirable 

Specialized Skills / Other Requirements

• Strong leadership and management skills
• Demonstrated experience in mentoring and coaching others
• Regulatory, cGMP, QSR, knowledge base
• Statistical knowledge (DOE, SPC, hypothesis testing, sample comparison)
• Strong computer skills (i.e. data-base development, statistical software and analysis, word processing for report generation, etc.)
• Strong negotiation and problem solving skills
• Ability to operate and communicate effectively with multiple teams
• Supplier auditing knowledge and ability (i.e. ASQ-CQA, internal/external courses, seminars)
• Able to understand blue prints, tolerance analysis and related knowledge
• Strong reasoning/analytical skills including the ability to, support and prioritize projects and adapt to shifting priorities 
• Work with minimal supervision
• Able to successfully resolve problems and conflicts 
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