Quality Manager – ISO 13485 & QMS Leader

FCX Performance; Sherwood (OR); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Health benefits

Competitive salary

Job summary

Olympus Controls is seeking a Quality Manager to lead a team of inspectors and maintain ISO 9001/13485 conformance. You will develop and manage the QMS, supervise calibration programs, and drive corrective actions with cross-functional teams to improve production efficiency.

You will collaborate with engineering, production, and RMA to ensure non-conforming materials are handled properly and that testing and documentation meet customer requirements. Health benefits and competitive salary offered.

Qualifications

• Three years of experience managing a quality department.
• Bachelor’s degree in manufacturing or related field, or seven years in manufacturing as alternative.
• Experience with ISO13485 and medical devices manufacturing.
• Experience implementing Quality Management Systems.
• Strong supervisory and leadership skills.

Responsibilities

• Manage a team of Quality Inspectors handling incoming, WIP, and finished goods inspections.
• Develop inspection methods and procure measurement tooling, including go/no-go gauges.
• Oversee calibration programs for production tooling.
• Develop and manage Olympus Controls’ QMS and internal audits.
• Coordinate with RMA to manage non-conforming materials and documentation.
• Lead corrective actions in response to customer findings.
• Collaborate with engineering and production to optimize lines and processes.
• Provide technical support to production and document SOPs and job aids.
• Perform FAT inspections and ensure testing is complete.
• Distribute non-conforming materials and coordinate vendor rework when needed.
• Drive continuous improvement and participate in meetings.
• Ensure compliance with RoHS, REACH, TSCA and related restricted substance programs.

Tools

ERP systems

Microsoft Office

MOM (Manufacturing Operations Management)

Job description

Olympus Controls is seeking a Quality Manager to lead a team of inspectors and maintain ISO 9001/13485 conformance. You will develop and manage the QMS, supervise calibration programs, and drive corrective actions with cross-functional teams to improve production efficiency.

You will collaborate with engineering, production, and RMA to ensure non-conforming materials are handled properly and that testing and documentation meet customer requirements. Health benefits and competitive salary offered.