Jt886 - Quality Systems Specialist

• Supports equipment and test method validation and supporting documentation as author or quality reviewer.  
• Supports process documentation changes as author or quality reviewer.
• Provides guidance and expertise to the team regarding quality and compliance procedures.
• Provides oversight for the development and maintenance of quality processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines.
• Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. 

• Bachelor's degree in Engineering
• 2 years of relevant experience with Quality systems
• Test Method Validation Analysis
• Change control of Medical Devices
• Equipment Commissioning / Qualification
• Process Validation
• Computer System Validation (CSV)
• Manufacturing, Packaging and Laboratory Equipment
• Technical experience (Trouble shooting) or any similar experience or background
• Quality / Process Control / Assurance of Medical Devices
• Process Validation and Computer software validation knowledge.
• Equipment Validations Manage Supplier Change Requests
• Availability for 1st shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.