Director of Quality Engineering - (US-MA-Mansfield - 02048)

Minimum Education: None
Jobcode: L:104492058
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Our client is experiencing tremendous growth, even during a down market and they are looking to build the quality leadership team via this strategic and forward looking addition to staff.
 
The Director, Quality Engineering will be responsible for every aspect of the company’s Quality Assurance program, to include Manufacturing Quality Engineering, Quality Control, Quality Systems and Design Assurance.   With two Quality Managers as direct reports, you will provide leadership to a group of 8-10 quality professionals while interacting and providing both tactical and strategic input to executive management, as related to Quality planning and programs.
Key Responsibilities:

Set priorities and manage all Quality related departments and budgets via 2 Quality Managers and 6-8 additional quality professionals.
Provide technical guidance and act as change facilitator for SPC, FMEA, DOE and process validation systems and programs.    Ensure product verification and validation is accurate and efficient systems are in place.
Support the implementation and continuous improvement of design and manufacturing processes that support a world-class Quality program through detailed Quality Engineering and compliance principles.
Manage the planning and oversight of Quality Control plans and Metrology and Inspection, assessing current practices for accuracy and championing a policy of continuous improvement.
Provide oversight and project management support for quality engineering as needed for product transfers and customer engagements.
Oversee the Quality Systems group, ensuring proper Document Control, Product Release, Complaint Analysis, and Corrective and Preventative Action Reporting.
Ensure all ISO13485 related training requirements are planned, prepared, conducted, and documented for the facility.
Coordinate Supplier, Internal and Customer Audits as necessary.
Ensure continuous compliance with FDA 21 CFR 820, ISO 13485:2003, ISO 14971, and other appropriate Federal, International Standards, local employment laws, and company policy.
Champion and comply with all work environment requirements, including those pertaining to safety, health, QSRs and the Quality Management System.

Minimum Qualifications:
·        Bachelors of Science Degree in a primary Engineering discipline (ME or EE preferred)
·        A minimum of 10 years in a regulated and technically advanced manufacturing environment, preferably medical devices – experience leading the quality assurance function in a medical device plastics, electronics, and electro-mechanical product environment is strongly preferred.         
·        3+ years of prior demonstrated experience managing or directing the Quality Assurance function for a manufacturing company, including Quality Control, Quality Systems, Design Assurance, and Manufacturing Quality Engineering.  
·        Strong technical competence and experience developing and overseeing Quality Control plans, Metrology, and Verification and Validation testing.
·        Strong competence and demonstrated effectiveness leading FDA 21 CFR 820, ISO 13485:2003, ISO 14971, and other appropriate Federal and International Standards .
·        Must be technically competent in SPC, DOE, Geometric Dimensioning & Tolerancing, mechanical drawings, and using computer assisted data analysis packages.
·        Able to assimilate complex engineering data and analysis into information that is useful for senior management decisions and priority setting.
·        Must possess the verbal and written communication skills and organizational competencies of a senior leader.