Process Quality Engineer

Introduction

We are looking for an experienced Process Quality Engineer to join our team!

About the Company

Intech is a global market leader and game-changer in the manufacturing of orthopedic medical devices. It all starts with innovation, and nobody knows this better than Intech. With manufacturing facilities around the world and unique initiatives and savoir-faire, Intech is at the forefront of technological innovation in the field of orthopedic device manufacturing as well as asset management, ensuring that optimal patient care is delivered day in, day out. This is who we are. We tech care.

Here at Turner Medical Inc. dba Intech we give our customers a competitive edge in today's highly specialized design and development of OEM orthopedic and spinal instrumentation. We manufacture world-class instruments to meet our customers' most demanding requirements.

About the Process Quality Engineer Role

Working as a Process Quality Engineer at Intech will give you the opportunity to gain experience in the quality process of creating complex spinal and orthopedic instruments that improve the lives of patients around the world! You will use sound and proven engineering principles, best practices, and concepts to assist in the developing processes and process requirements from internal and external stakeholders. The Process Quality Engineer ensures that products meet the required quality standards during the manufacturing process. Responsibilities focus on implementing quality control measures, conducting inspections, and identifying opportunities for process improvement.

Essential Duties and Responsibilities:

• Develop and implement quality control procedures and guidelines for the manufacturing process.
• Conduct inspections and tests to ensure that products meet quality standards and customer requirements.
• Evaluate manufacturing processes to identify potential areas of improvement.
• Analyze data to pinpoint bottlenecks, defects, and inefficiencies. Work with cross-functional teams to address these issues and enhance the overall manufacturing process.
• Ensure that manufacturing processes adhere to industry-specific quality standards, regulations, and certifications.
• Stay up to date with the latest quality requirements and work to implement necessary changes in processes and procedures.
• Create and maintain detailed quality documentation, including inspection reports, quality standards, and testing protocols.
• Investigate defects, non-conformities, and quality issues to determine their root causes. Implement corrective and preventive actions to address these issues and prevent their recurrence.
• Collaborate with suppliers to ensure that raw materials and components meet quality standards.
• Conduct supplier audits and inspections as necessary to verify the quality of incoming materials.
• Provide training to production and quality assurance staff on quality control procedures and best practices. Foster a culture of quality within the organization.
• Conduct regular internal quality audits to assess compliance with quality standards and identify areas for improvement. Collaborate with internal teams to address audit findings and implement changes.
• Collect and analyze customer feedback and complaints related to product quality. Use this feedback to drive improvements in manufacturing processes and product quality.
• Work on continuous improvement initiatives to enhance product quality and manufacturing efficiency. Implement statistical process control (SPC) methods and other quality improvement tools to monitor and improve processes.
• Work closely with cross-functional teams, including engineering, manufacturing, and product management, to ensure that quality considerations are integrated into the product development and manufacturing processes.
• Use data analysis tools and techniques to monitor and analyze quality metrics, identify trends, and make data-driven decisions to improve the manufacturing process.
• Communicate quality-related updates and concerns to stakeholders, including management, suppliers, and internal teams. Provide regular reports on quality performance and improvement initiatives.

Job Qualifications

• Bachelor's degree in engineering or related technical field preferred. Will consider equivalent combination of related experience and/or training.
• Strong background in quality management, statistical analysis, and problem-solving.
• Minimum of 3 years in ISO/FDA machine shop, contract manufacturer experience preferred.
• Understanding how to read and interpret Geometric Dimensioning and Tolerancing (GD&T) callouts on part prints to effectively run quality parts.
• Knowledge of precision measuring instruments and the application of such instruments. Instruments should include but not limited to calipers, micrometers, depth gages, indicators, and scales.
• Must be adaptable to a changing environment, competing demands and is able to deal well with frequent change, delays, or unexpected events.
• Critical thinking, advanced decision-making skills, and mechanical aptitude.
• Ability to identify varied materials and their relationship to design (form, fit, and function).
• Ability to read, comprehend, follow, and document work instructions, blueprints, routers, and SOPs.
• Ability to collaborate and assist team members, provide input to the area lead, and attend/participate effectively in meetings.
• Ability to communicate and interact effectively, professionally, and constructively.
• Comply with and maintain 5S and safe work environment practices.
• Experienced in a medical device, ISO/FDA, job shop environment preferred.