The Quality Assurance Engineer will support Meridian's Quality Policy and Meridian's Operating Procedures and provide effective solutions for success. This individual will be actively involved with Quality System Management, Quality Improvements and must have a constant awareness of Customer Requirements. Responsible for the quality process used for Manufacturing and their associated engineering/control functions which involves monitoring and overseeing utilization of all parts of the process. This position will take a lead role in various aspects of the QMS system, i.e. CAPA's, Internal and External Audits, Complaint Investigations, Product release, MRB, and Quality Reports. Must be familiar with both FDA (CFR 820) and ISO 9001/13485 standards; IVD experience a plus. This person will be key in interpreting and implementing US law, EU Directives and/or local requirements as it pertains to Magellan Diagnostics and the medical industry in general.
Responsible for the overall quality engineering and related supporting activities involving Instruments, Sensors and the Reagents of Meridian’s products and systems.
Evaluate the manufacturing process in the Reagent/Sensor Manufacturing area; assist with procedures, data collection points, and review processes to make improvements as required.
Take a leadership role in specific aspects of the Quality Management System such as the CAPA system, developing and maintaining reports to support the QMS system, and improvements to the system.
Must be able to locate, read and interpret US and Foreign standards and guidelines as they pertain to our instruments. ISO and FDA Code of Federal Regulations, and various local, state and federal or country laws or directives. i.e., International registrations, EU Directives, country specific laws.
Familiar with design controls and ability to create and review validations, IQ, OQ and PQ documents for the existing and new processes.
Review and improve documentation for raw materials, specifications, BOMs testing/Quality Control.
Support and improve Supplier Quality Control processes including QE review of technical specification, product acceptance activities, supplier qualification, and ongoing maintenance of the approved supplier list. This also includes supplier audits.
Perform Quality System audits.
Excellent drive, motiviation, and flexibility – the ability to work and think independently in a fast paced, changing environment and to deliver on commitments.
The ability to work independently with minimal supervision.
BS in Engineering or Life Sciences plus minimum 5 years of experience in manufacturing, laboratory or quality position supporting FDA regulated products
Skills, Specialized Knowledge and Abilities:
Able to use Microsoft Office (Microsoft Word, Excel, PowerPoint)
Extensive Quality Engineering experince in the manufacturing sector, experience in the Aerospace, Automotive, medical Device or IVD industries is a plus.
Working knowledge ofFDA medical device, IVD, device regulations, ISO 13485, is a plus.
Solid analyitical skills, espcially problem solving, root Cause analysis, statistical sampling, etc. Ability to oversee the change control process, lead Corrective Action Process, MRB for product noncoformities, .
Previous experience with electronic document management systems preferred
Ability to read, understand and follow all company SOPs and guidelines.
Ability to communicate (written and verbal) and interact effectively with all levels of the organization.
Good organizational skills and strong attention to detail.
Must be able to perform job requirements independently with minimal supervision.
Adjusts easily and readily to a fast-paced work environment with changing priorities
Ability to maintain regular attendance and punctuality requirements.
Must be available to work hours outside the normal work shift (evenings or weekends) as needed to meet business needs.
Requirements (Physical, Mental, Environmental Demands):
Must be able to wear personal protective equipment (lab coat, latex or nitrile gloves, safety glasses, etc) when on the production floor
Must be able to adhere to applicable biosafety practices when on the production floor or in laboratories
Must be able to concentrate, analyze and solve complex issues throughout the course of the work shift.
Ability to travel by car/air to other locations to conduct inspections, training or investigations.
Ability to work on PC including repetitive use of a keyboard and mouse for long periods throughout the course of the work day
Must be able to meet National Institute for Occupational Safety & Health (NIOSH) Standards.
Work Environment: Office with some laboratory work with exposure to physical elements (blood/human samples)
Physical Requirements: Must be able to meet National Institute for Occupational Safety & Health (NIOSH) Standards.
We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing.