Quality Leader for Medical Device Manufacturing Compliance

Angel Aligner; Oak Creek (WI); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

Angel Aligner in Oak Creek, WI, seeks a Quality Manager to lead daily quality operations in a medical device manufacturing environment, ensuring products, processes, and documentation meet FDA, ISO 13485, and internal quality system requirements. This role oversees inspectors and technicians, supports production, and drives compliance and audit readiness.

You will manage a team, review records and DHRs, support CAPA activities, monitor quality trends, facilitate internal and external audits, and

Qualifications

• Bachelor's degree in Quality, Engineering, Life Sciences, or related field preferred; equivalent experience accepted.
• 3+ years of experience in quality assurance within medical device, pharmaceutical, or regulated manufacturing.
• 1+ years of leadership or supervisory experience.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and GMP principles.
• Experience with inspection tools, measurement systems, and quality documentation.
• Proficiency with eQMS systems and Microsoft Office.
• Strong communication, coaching, and conflict-resolution skills.
• Ability to interpret engineering drawings, specifications, and inspection standards.

Responsabilités

• Manages a team of quality inspectors and quality technicians, including scheduling, training, and performance management.
• Ensures in-process and final inspections are completed accurately and on time.
• Reviews and approves inspection records, device history records (DHRs), and nonconformance reports.
• Supports investigations, root cause analysis, and CAPA activities.
• Monitors production quality trends and escalates issues proactively.
• Ensures compliance with FDA 21 CFR Part 820, ISO 13485, and internal SOPs.
• Supports internal and external audits by preparing documentation and leading inspection activities.
• Collaborates with manufacturing, engineering, and regulatory teams to resolve quality issues.
• Oversees calibration, equipment checks, and quality-related preventive maintenance.
• Trains employees on quality procedures, inspection methods, and documentation requirements.
• Drives continuous improvement initiatives to reduce defects and improve process capability.
• Ensures proper handling, segregation, and disposition of nonconforming material.

Connaissances

Leadership

Quality mindset

Communication

Training

Coaching

Formation

Bachelor's degree in Quality/Engineering/Life Sciences

Outils

eQMS

MS Office

Measurement tools

Description du poste

Angel Aligner in Oak Creek, WI, seeks a Quality Manager to lead daily quality operations in a medical device manufacturing environment, ensuring products, processes, and documentation meet FDA, ISO 13485, and internal quality system requirements. This role oversees inspectors and technicians, supports production, and drives compliance and audit readiness.

You will manage a team, review records and DHRs, support CAPA activities, monitor quality trends, facilitate internal and external audits, and