Quality Leader — Regulated Manufacturing & Compliance

The Judge Group; Portland (OR); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Matching 401k

Relocation offered

Job summary

The Judge Group seeks an experienced Plant Quality Manager to lead Quality Assurance and Quality Engineering within a regulated manufacturing environment in Portland, OR. The role drives quality planning, CAPA, and continuous improvement across product development and production.

The ideal candidate has 7+ years of quality leadership in regulated settings, strong FDA/ISO knowledge, and ASQ CQE certification. Relocation is offered if needed, along with a solid benefits package.

Qualifications

• Bachelor's degree in Engineering, Science, or related field.
• 7+ years of quality leadership in a regulated industry with 4+ years in management.
• Background in regulated manufacturing environment, preferably medical devices.
• Strong knowledge of FDA Quality System Regulations, ISO 13485, MDR, and quality mgmt systems.
• Experience leading large quality teams (20+ members) and supporting regulatory audits.
• ASQ Certified Quality Engineer preferred.
• Advanced statistical analysis and problem-solving skills.
• Continuous improvement experience preferred.

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.

Education

Bachelor's degree in Engineering, Scientific Discipline, or related field

ASQ Certified Quality Engineer

Quality leadership

Advanced statistical analysis

Problem-solving skills

Job description

The Judge Group seeks an experienced Plant Quality Manager to lead Quality Assurance and Quality Engineering within a regulated manufacturing environment in Portland, OR. The role drives quality planning, CAPA, and continuous improvement across product development and production.

The ideal candidate has 7+ years of quality leadership in regulated settings, strong FDA/ISO knowledge, and ASQ CQE certification. Relocation is offered if needed, along with a solid benefits package.