Plant Quality Manager

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

Benefits offered by this job

Annual bonus

Relocation assistance

Job summary

Judge Direct Placement seeks an experienced Quality Manager to lead the Quality functions within a regulated FDA manufacturing environment.

Responsibilities include leading QA and QE teams, ensuring compliance with FDA, ISO 13485 and MDR, overseeing CAPA, audits and continuous improvement initiatives, and partnering with suppliers to resolve quality issues.

Qualifications

• Bachelor's degree in Engineering or related field.
• 7+ years of quality leadership in regulated industry with 4+ years in management.
• Experience in regulated manufacturing environments, preferably medical devices.
• Strong knowledge of FDA QSR, ISO 13485, MDR and QMS.
• Experience leading large teams and regulatory audits.

Responsibilities

• Lead site Quality Assurance and Quality Engineering teams.
• Ensure compliance with FDA, ISO 13485, MDR and quality regs.
• Oversee CAPA, nonconformance management, MRB and quality investigations.
• Support product development and manufacturing via quality planning, statistics and process controls.
• Monitor quality metrics, objectives, training, and continuous improvement.
• Lead internal, customer and regulatory audits.
• Manage product and process quality issues using formal problem-solving methodologies.
• Partner with suppliers to improve product quality.

Skills

Quality leadership

Regulatory knowledge

Statistical analysis

Process controls

Audit management

Cross-functional leadership

Education

Bachelor's degree in Engineering or related field

Tools

QMS

Job description

We are seeking an experienced Quality Manager to lead the Quality functions within a regulated FDA 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.
• Solid continuous improvement experience is preferred.
• Advanced statistical analysis and problem-solving skills.

Excellent compensation package including annual bonus and relocation is offered. Company has a comprehensive benefits package including medical, dental, vision, matching 401k and more.