Experience Requirements
Minimum 7-8 years QA engineering experience in a medical device manufacturing environment.
Qualification Requirements
Regulatory cGMP, QSR and ISO knowledge base. Computer literate (MS Word, Excel, Access, PowerPoint, and Mini-tab preferred). Negotiation and problem solving skills. Good oral and written communication skills. Statistical Skills (DOE, SPC, Reliability, Gage R&R). Experience with risk analysis methodologies. Experience in the area of manufacturing operations. Ability to prioritize and work independently. Validation concepts & techniques (process, equipment, and gauging). Experience developing training programs. Able to work independently with limited supervision.
Preferred Qualifications
ASQ certification highly desired.
Responsibilities
Position Summary:
This position will provide technical support and take a leadership role in quality engineering functions in manufacturing and product development in compliance with FDA 21CFR Part 820, ISO 13485, and internal procedures.
Primary Responsibilities:
Direct quality activities in manufacturing such as inspection methods and Material Review Board (MRB).
Support product development such as design change and review, quality planning, risk evaluation, and validation.
Supervise Quality Assurance Inspectors if needed.
Coordinate Corrective and Preventive Action (CAPA) for customer, internal, and vendor related needs.
Audit internal and vendor processes and procedures.
Participate in Continuous Improvement Projects (CIP) for both processes and business systems.
Develop training programs for inspection and engineering.
Represent company during customer or regulatory audits as needed.
