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Quality Manager

PRINCIPAL RESPONSIBILITIES
Management and development of staff in two facilities; ensure 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 or MBA preferred.
Minimum of 3 years medical device industry experience
Minimum of 3 years related quality experience in a manufacturing environment
Minimum of 2 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
TRAVEL REQUIRED: Up to 40% (Travel consists primarily of driving between 2 company locations in MA and CT)
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

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