Quality Manager
judge groupPortland (ME)
About the role
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.#JDP
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