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Quality Engineer - Manufacturing & Process Control

Company Overview
Located in a vibrant McMinnville, World Class Technology Corporation is a leading manufacturer specializing in orthodontic appliances and metal injection molding. Renowned nationally and internationally, we are committed to delivering innovative, high-quality products through advanced manufacturing processes.

Overview
We are seeking a dynamic and detail-oriented Quality Engineer focused on Manufacturing and Process Control to join our team. In this role, you will drive quality excellence across production lines, ensuring compliance with industry standards such as ISO 13485 and FDA regulations. This role will work closely with Quality Assurance, Engineering, Regulatory, and Document Control, to improve in-house manufacturing quality systems, reduce variations, strengthen process capability and support a culture of disciplined execution and continuous improvement.

The ideal candidate is especially strong in internal manufacturing quality, process control, metrology, statistics, validation support and practical problem solving on the production floor. This person must be capable of translating quality requirements into clear, effective action and of teaching operators, technicians, engineers and leaders how to better control processes and prevent defects. They must old the ASQ Certified Quality Engineer (CQE) credential and have demonstrated quality performance within an ISO based quality system.

Duties

Develop, implement, and monitor manufacturing quality control procedures aligned with industry standards and regulatory requirements.
Conduct comprehensive quality audits to verify adherence to ISO 13485 and FDA regulations and support external auditors during scheduled audit visits.
Lead root cause analysis investigations for process deviations or product non-conformities; implement corrective and preventive actions.
Support NCMR/CAPA processes and regulatory compliance.
Perform quality inspections and assurance activities throughout the manufacturing process to ensure product integrity.
Collaborate with cross-functional teams (Quality Assurance, Manufacturing, and Regulatory / Document Control) on project management initiatives aimed at process improvements and quality enhancements.
Maintain detailed documentation of quality systems activities, audit reports, inspection records, and compliance reports.
Facilitate ongoing training on quality management systems and regulatory compliance for manufacturing staff.
Lead or support Gauge R&R and MSA activities and Improve measurement systems.
Analyze quality and process data to identify trends, risks, and opportunities.

Experience

Proven experience in manufacturing environments with a strong focus on quality control and assurance.
ASQ Certified Quality Engineer (CQE) required
Bachelor's degree in engineering, quality, manufacturing, or related field (or equivalent experience).
Hands-on knowledge of ISO 13485, FDA QSR (21CFR Part820), AS9100, or IATF16949.
Experience conducting quality audits and implementing QA/QC procedures within regulated industries.
Strong analysis skills to identify process issues and develop effective solutions.
Familiarity with quality systems management tools and project management methodologies.
Demonstrated ability to lead continuous improvement initiatives in a fast-paced manufacturing setting. Join us to be part of a passionate team dedicated to excellence in manufacturing quality! Your expertise will help shape the future of our innovative products while ensuring the highest standards of safety and performance are met every step of the way.

Pay: $78,000.00 - $90,000.00 per year

Benefits: