Quality Engineer

We are seeking a Quality Engineer to provide quality engineering support for the critical quality systems for the production of regulated medical devices including: Process Validation, Corrective and Preventive Action, Customer Complaint Investigations / MDR reporting, and Supplier Management to ensure conformance to industry practices, regulatory requirements and established company procedures for medical devices
Job Duties:
Specialize in areas of quality control engineering, such as design, incoming material,process control, product evaluation, system performance hardware performance, product reliability, inventory control, metrology, automated testing, software, research and development and administrative application
Develop and execute validation activities, such as IQ/OQ/PQ
Ensure activities and items are in compliance with both company quality assurance standards and applicable government regulations, such as GMPs and ISO requirements
Develop, modify, apply, and maintain quality standards and evaluation methods for products and processes
Provide moderately complex statistical information for quality improvement by determining and applying testing methods and criteria. May perform gap assessments and support the implementation of site procedure changes
Apply effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality and compliance issues
Establish and maintain good customer rapport, while driving solutions to meet business needs. Develop and maintain a strong spirit of partnership
May assist in the development of contracts and procedures to ensure compliance
Skills Required:
Knowledge and experience with applicable FDA regulatory requirements and Quality Management Systems for regulated medical device is required
Must be accurate, attentive to details, creative, innovative, and must understand and adhere to Standard Operating Procedures, QSRs (Quality System Regulations), FDA 21 CFR part 820 and other government regulations and have a thorough understanding of cGMPs for medical devices
ISO 13485:2003 knowledge and experience is desired but not required
Demonstrated knowledge of Quality Assurance methods, such as process validation, design and process FMEA, statistical process control (SPC) and protocol/report preparation
Also required is demonstrated evidence of a solid background of technical knowledge and experience combined with the proven ability to successfully direct projects and influence people at all organizational levels
LEAN problem solving and standard work exposure preferred
Experience/Schooling or Degree Required:
Requires a Bachelor's degree in a science, engineering or related discipline and a minimum of 3 years' experience in Manufacturing, a Quality function, within medical device
Experience should include close working relationships with Manufacturing and Engineering functions
Experience interacting with internal/external auditors is a plus
Experience with electronic document control systems is desirable.
Phone: 801-572-4200

Don't Be Fooled

The fraudster will send a check to the victim who has accepted a job. The check can be for multiple reasons such as signing bonus, supplies, etc. The victim will be instructed to deposit the check and use the money for any of these reasons and then instructed to send the remaining funds to the fraudster. The check will bounce and the victim is left responsible.