Quality Manager (1153514)

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

Location: Portland, OR

Salary: $130,000.00 USD Annually - $170,000.00 USD Annually

Plant Quality Manager

We are seeking an experienced Quality Manager to lead the Quality functions within a regulated manufacturing environment.

Key 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.

Qualifications

• Bachelor's degree in Engineering, Scientific Discipline, or related field.
• 7+ years of quality leadership experience in a regulated industry, with 4 years of management experience
• Must have a solid background in a regulated manufacturing environment, preferably medical devices.
• Strong working knowledge of FDA Quality System Regulations, ISO 13485, MDR, and quality management systems.
• Experience leading larger quality teams (20+ min) and supporting regulatory audits.
• ASQ Certified Quality Engineer is preferred
• Solid continuous improvement experience is preferred.
• Advanced statistical analysis and problem-solving skills.

Great opportunity to join an amazing organization and grow with in the future! Solid benefits package to include medical, dental, vision, matching 401k and more!

Relocation is also offered if needed.