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:

Process Engineer – direct hire / full time

Reports to:

Engineering Manager

Department:

Advanced Process Engineering

Location:

Allen, TX 75002

Summary:

Supports daily manufacturing operations, product development, and activities associated with process improvement, validation, QA systems, and technology development

Requirements:

• Bachelor’s degree or an acceptable combination of experience and education
• A minimum of one year experience in the medical device manufacturing industry or related field
• Ability to communicate effectively at all levels of personnel
• Proficient with major software tools including MS Office, MS Project, SolidWorks, and statistical analysis software.
• Familiar with automated manufacturing equipment
• Possess above average writing, analytical, and communication skills

Duties:

• Perform duties and responsibilities under the direct supervision and leadership of the Disposables Engineering Manager and/or senior engineering personnel.
• Support new product development and line extensions to meet company goals, including product testing and validations, process development, and creation of manufacturing documentation.
• Identify, justify and implement equipment upgrades, new product and process technologies, and process improvements.
• Understand basic requirements of design control during product and/or process development projects.
• Understand quality system requirements of customers, FDA, QSR, and other regulatory agencies, and use quality tools to improve processes and products within those standards.
• Perform analysis of data and report results in a technical report.
• Perform root cause analysis and recommends resolution of problems associated with products, manufacturing processes, and customer complaints. Draft engineering change order reports to support these corrective actions.
• Perform design verification and validation activities which meet all necessary requirements of a project, including master validation planning, design of test methods, and drafting qualification documents ranging from equipment qualification to product validation.
• Manage complaint investigation activities for required product lines consisting of failure investigation, root cause analysis, and corrective and preventative action implementation for complaint issue. Contribute to non-conforming material report discussions.
• Support, coordinate, and/or lead projects requiring cross-functional team participation to meet project goals.
• Possess technical writing, project management and fundamental problem-solving skills.
• Able to apply advanced mathematical concepts and statistical analysis.
• Provides supporting role for senior engineering personnel in all aspects of medical device manufacturing engineering.

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 and other excellent benefits

An Equal Opportunity Employer