FullTime
Allen, TX
Posted 1 month ago

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.

 

Position Title:

Quality Operations Engineer I – direct hire / full time

 

Reports to:

Quality Operations Manager

 

Department:

QA/RA

 

Location:

Allen, TX 75002

 

Summary:

Prioritizes and coordinates the activities of Quality Control Technicians at Incoming QC, In-Process QC (Disposables and Electronics), and Finals QC to ensure adherence to established quality standards.  Leads projects and improvement efforts to ensure all QC activities are being performed in the most efficient and cost effective manner possible. Provides support to Quality Control Technicians/Leads while ensuring internal/external customer demands are being met.  Establishes inspection procedures, defines sampling plans based on risk assessments, and qualifies test methods and inspection equipment.  Provides the necessary training to ensure employee competency.  Incorporates themselves into cross-functional team meetings for process improvements, audits, CAPA and project work.  Performs root cause investigations for internal non-conformances and support activities around those investigations, as necessary.

 

Requirements:

  • Bachelor of Science degree in a technical area such as science, engineering, math or equivalent experience.
  • 1-3 years of experience in a quality role in a regulated industry such as medical device or pharmaceutical.
  • Ability to work well on a team and has a cooperative attitude.
  • Knowledge in MDSAP, FDA Quality System Regulation, MDD, and/or ISO 13485.
  • Organization skills must be at a high level in order to ensure all personnel are achieving goals and tasks
  • Must possess technical writing, project management and fundamental problem-solving skills.
  • Excellent writing and communication skills. The individual should be detail oriented and have good deductive and problem-solving skills.
  • Supervisory experience desired.
  • Self-motivated employee that does not need to receive direct supervision to carry out day to day activities.

 

Responsibilities:

  • Prioritizes and coordinates QA Technicians, ensuring that the required inspections are being performed per company policies and procedures and the necessary resources are available.
  • Lead/participate in projects to ensure the health of the Quality Operations group, as well as the Quality Assurance Department as a whole. This projects may be dictated by management or self-identified projects.
  • Ensure that each QA Technician fulfils the production/customer order needs throughout the company.
  • Oversee inventory levels in, both, all M-locations and Q-locations in the ERP system.
  • Administrate the Environmental Monitoring Program, including the performing of any tests and submitting necessary test samples to laboratory to ensure compliance to internal procedures.
  • Provide inputs into and ensure the outputs from Material Review Board activity and Non-Conforming Material Reports (NCMR) are being executed on a timely basis, including re-inspection and QC disposition activities.
  • Maintain the employee competency matrix to monitor training progress and cross-training needs.
  • Work to improve all aspects of quality control inspections, especially efficiency and cost reduction when applicable. This includes sourcing new equipment to perform inspections, methodologies of inspections, and streamlining the inspection process.
  • Lead method development for quality inspections using new technology.
  • Audit each inspection area on a regular basis to ensure compliance to all company policies and procedures.
  • Use project management tools to calculate estimated time for performing a series of tests within the normal inspection process. Make recommendations about procedures for optimizing the testing process.
  • Make necessary updates to controlled documentation in order to facilitate continuous improvement in all aspects of the Quality Control process.
  • Write technical reports associated with qualifications, quality improvements and CAPA projects.
  • Lead and participate in department’s step-up program.

 

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

 

An Equal Opportunity Employer

 

Job Features

Job Category

Engineer, Quality

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