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Director of Quality
Athens, OH 45701 US
Job Description
The Director of Quality Assurance is accountable for creating, managing, continually improving and directing the Quality Management System for the division in accordance with Corporate Quality Management Systems, ISO 13485 standards and all matters of regulatory compliance.
Job Requirements:
- Knowledgeable about and experience with compliance to Quality Management Systems best practices, regulatory affairs/product safety and ISO 13485 Standards
- Experience overseeing a Quality Program for hardware and software products
- Experience writing validation studies and interpreting results
- Experience with basic statistical analysis
- Ability to creatively collaborate with team members
- Proficient in Microsoft Office programs
- Ability to lead, manage and coach team members
Job Specifications:
- A minimum of a bachelor’s degree in Engineering or Science related curriculum with a minimum of 8 years working in Quality Assurance
- A minimum of two years leading, managing and coaching a team
- Experience managing in a medical device environment including 21CFR 820 and/or MDR.
- Experience implementing and/or maintaining an ISO 13485 certified Quality Management Systems
- Familiarity with with Regulatory Affairs and Managing Certificates of Conformance
- Affiliation with Quality Professional Organization(s) such as ASQ and associated certifications (CQM/OE, CQE, etc.) desired
- Data management and basic statistics
Meet Your Recruiter
John Ellison
John has 30 years of experience recruiting professionals in the high-tech space. He possesses strong knowledge of recruiting strategies for permanent and contract placement. Additionally, he has 11 years of direct client interface sales and marketing experience for the staffing industry.
