Cubbison Company is seeking a Medical Quality Engineer to develop and implement quality assurance activities in the design, development, manufacture, and service of medical devices including leading the efforts in quality system development, training, and maintenance; device master record review and approval; internal and regulatory audits; and CAPA activities.
We are searching for a candidate who possesses the leadership to determine the system needed as well as the confidence to carry out all required activities to bring the products to market and achieve compliance to requirements.
Primary Responsibilities and Duties:
Work proactively with management and staff to develop and implement quality system strategies that maintain high standards of quality, reliability, and safety.
Put the quality management system into practice for the newly developed product lines
Serve as the subject matter expert on regulatory affairs and quality management systems
Provide leadership in system development throughout the quality management system
Develop, review and approve quality system SUP, WI, and QF documents
Review and approve device master record documents.
Serve as point person for regulatory inspections and audits, specifically ISO 13485 certification audit.
Serve as the main interface for all customer quality requirements
Review and approve engineering verification and validation protocols.
Work proactively with R&D development teams to plan, develop, and deliver medical devices that satisfy customer needs.
Lead preparation and approval of risk management documentation.
Review and approve design and manufacturing verification and validation protocols.
Lead CAPA investigation and documentation.
Other duties appropriate to position or as assigned by management.
Bachelor's Degree or equivalent in Engineering, Science, or technology field
Minimum 5 years of experience in QE capacity engineering in a manufacturing environment. Medical or pharmaceutical experience desirable.
Experience with creation/maintenance of Quality systems.
Working knowledge/familiarity with USA FDA QSR, ISO 13485, 21 CFR 820 and cGMP requirements.
Experience developing and implementing quality systems.
Working Knowledge of quality engineering tools and statistical quality control techniques
Experience performing quality auditing
ASQ Certification as CQE, CRE, or CSQE desirable.
Additional Salary Information: Salary is negotiable.
Cubbison is a manufacturer of industrial and commercial product identification products and flexible electronic devices. We serve a diverse group of commercial and industrial customers and end-markets across the Americas, Europe, and Asia. Our products are engineered to order and customized to meet precise requirements.