Quality Engineer

My client is seeking a highly skilled and detail-oriented Quality Engineer to join their team. They are a leading Medical Device Contract Manufacturer. The successful candidate will play a pivotal role in ensuring the highest standards of quality are maintained throughout the manufacturing process, from product development to delivery. This position requires a deep understanding of quality systems and lean manufacturing.

Client Details

Our client is an end-to-end solution provider from design and development to finish device manufacturing and assembly. They go back almost five decades and have been strategically building our capabilities portfolio to offer their customers a complete, end-to-end solution for their medical device needs.

Description

The Quality Engineer II will be responsible for:

• Develop, implement, and maintain effective quality management systems in compliance with relevant regulatory standards.
• Conduct regular internal audits to assess compliance with established quality procedures and standards.
• Collaborate with cross-functional teams to drive continuous improvement initiatives within the quality management system.
• Design and execute process validation protocols, ensuring that manufacturing processes consistently meet established quality standards.
• Analyze and interpret validation data, providing recommendations for process improvements as needed.
• Collaborate with suppliers to establish and maintain quality standards for incoming materials.
• Conduct supplier audits and assessments to ensure adherence to quality requirements.
• Resolve quality issues with suppliers and drive corrective and preventive actions.
• Implement and maintain risk management processes in accordance with ISO 13485.
• Conduct risk assessments for new and existing products and processes, identifying and mitigating potential risks.

Candidates will be provided full job description upon application and consideration. Please submit your resume for consideration within 48 hours. Relevant candidates can expect to hear back within 48 hours of submission.

Profile

The successful Quality Engineer II will have:

• Bachelor's degree in Engineering or a related field or Related Work experience
• Experience working in an ISO 13485 regulated environment
• Experience with risk management processes, process validation, and supplier quality management.
• Experience with Gauge R&R, CMM, and GD&T
• Excellent communication and interpersonal skills.

Job Offer

If you are interest in this position, please contact me at or you can directly apply below. This position included a competitive salary and bonus structure that is comparable with current salary and experience.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.