Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 10+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.
Quality Engineer II – direct hire / full time
Director, QA/RQ or Quality Systems Manager
Allen, TX 75002
Responsible for maintaining and improving the quality management system. Performs activities to support quality aspects of design and development, manufacture, and post-production of components and finished products. Conducts Corrective and Preventive Action activities to investigate causes of non-conformance, determine root cause and implements corrective actions to eliminate quality problems. Provides support and leadership to teams focused on CAPA. Supports supplier quality program by performing audits, managing supplier metrics, and managing supplier corrective action plans. Develops various product tests and conducts data analysis. Develops qualification test protocols and generates reports as needed. Provides guidance on engineering projects. Supports the internal and external quality audit program. Uses statistical tools to analyze data, make acceptance decisions, and improve process capability.
Bachelor of Science degree in a technical area such as science, engineering, math or equivalent experience is required. Master of Science degree in Engineering or Quality Assurance is preferred.
A minimum of 3 years of experience in a quality role in a regulated industry such as medical device or pharmaceutical is required.
American Society of Quality (ASQ) Certification (CQA, CQE, SSBB, etc.) preferred.
Familiar with FDA Quality System Regulation, MDD, ISO 9001, ISO13485, and ISO 14971.
Strong unbiased advocate of compliance.
Ability to lead efficient project teams.
Must possess technical writing, project management and fundamental problem-solving skills.
Experience using word processing, spreadsheet, data management and/or design of experiments software programs. Familiarity with Minitab statistical software.
Experience as a Lead auditor of quality management systems.
Excellent verbal and written communication skills.
Ability to travel up to 10% of the time.
Support daily manufacturing activities and work with Engineers to resolve line issues and implement corrective actions.
Provide technical support for incoming inspection and lot release testing activities.
Provide support and leadership to Product Improvement Teams as Quality Engineer.
Manage customer complaint investigations from initiation through investigation and closure. Ensure reportability assessments are made in a timely manner for each complaint. Ensure quality, in-depth investigations are performed, including effective root cause and corrective action assessments.
Manage NCMR investigations from initiation through investigation and closure. Perform product dispositions in a timely manner. Ensure quality, in-depth investigations are performed, focusing on elimination of the defect condition through effective root cause and corrective action problem solving techniques.
Provide input to the Supplier Quality program by evaluating potential suppliers, managing supplier corrective actions, performing supplier audits, and evaluating quality metrics.
Support the Internal Audit program by auditing, identifying and correcting deficiencies, creating reports, and conducting verifying effectiveness of corrective actions.
Provide quality engineering support to engineering project teams associated with new product development projects or process improvement projects. With Management support, review and approve all studies, qualifications, and engineering change orders associated with the project.
Develop and revise quality system procedures (SOPs and WIs).
Develop/ write protocols and coordinate the testing for validation activities, component qualification activities, IQ/OQs, test method validations, and Gage R&R studies.
Develop and maintain risk management files and quality control plans for components, devices and processes.
Provide training and/or technical guidance to QA Technicians and production staff as required.
Uses statistical analyses and interpretations for investigations, specification setting activities, and test protocols.
Participate in inspections with FDA, ISO, MDD, MDSAP and other regulatory agencies.
Lead major quality projects which result in CPAR files.
Use effective problem solving techniques to support successful completion of job duties.
Strive to constantly innovate and implement improvements for improved methods for testing components.
Works under general supervision. Relies on instructions and pre-established guidelines to perform the functions of the job.
May have dotted line supervision responsibility.
Notables / Benefits:
Mid-size company with great company culture that is well diverse
Have a voice in the company
Average tenure for employee population is 10-+ years
401k with employee matching available
Paid vacation, health/dental/vision, and other excellent benefits