Senior Quality Manager - Medical Devices | Relocation

The Judge Group; Portland (OR); On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) matching

Relocation assistance

Job summary

The Judge Group is seeking a Plant Quality Manager in Portland to lead QA and QE teams in a regulated manufacturing setting. You will ensure compliance with FDA/QMS standards and drive CAPA, audits, and continuous improvement across the site.

Ideal candidates bring 7+ years of quality leadership, strong regulatory knowledge, and a track record of managing large teams. Relocation assistance available and a comprehensive benefits package.

Qualifications

• Bachelor’s degree in Engineering, Science, or a related field.
• 7+ years leading quality teams in a regulated industry with 4 years of management.
• Background in regulated manufacturing, preferably medical devices.
• Strong knowledge of FDA QSRs, ISO 13485, MDR, and QMS.
• Experience leading 20+ person teams and supporting regulatory audits.
• ASQ CQE is preferred.
• Continuous improvement experience desirable.
• Advanced statistical analysis and problem-solving skills.

Responsibilities

• Lead and develop site Quality Assurance and Quality Engineering teams.
• Ensure compliance with FDA, ISO 13485, MDR, and applicable quality regulations.
• Oversee CAPA, nonconformance management, material review boards, and quality investigations.
• Support product development and manufacturing through quality planning, statistical analysis, and process controls.
• Monitor quality metrics, department objectives, training programs, and continuous improvement initiatives.
• Lead internal, customer, and regulatory audits.
• Manage product and process quality issues using formal problem-solving methodologies.
• Partner with suppliers to improve product quality and resolve quality concerns.
• Provide leadership for validation, calibration, quality engineering, and related quality operations functions.

Skills

Quality leadership

Regulated manufacturing

FDA/ISO knowledge

Audit management

CAPA & NCM

Statistical analysis

Education

Bachelor’s degree in Engineering/Science

ASQ Certified Quality Engineer

Tools

Quality management systems

Job description

The Judge Group is seeking a Plant Quality Manager in Portland to lead QA and QE teams in a regulated manufacturing setting. You will ensure compliance with FDA/QMS standards and drive CAPA, audits, and continuous improvement across the site.

Ideal candidates bring 7+ years of quality leadership, strong regulatory knowledge, and a track record of managing large teams. Relocation assistance available and a comprehensive benefits package.