Quality Manager

About the Role

The Quality Manager leads daily quality operations within a medical device manufacturing environment, ensuring products, processes, and documentation meet FDA, ISO 13485, and internal quality system requirements. This role oversees quality inspectors/technicians, supports production teams, drives compliance, and ensures consistent product quality and audit readiness.

Responsibilities

• 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.

Requirements

• 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.

Preferred Qualifications

• Experience in clear aligners, orthodontics, dental devices, or custom-manufactured devices.
• ASQ CQE, CQA, or Six Sigma certification.
• Experience with 3D printing, thermoforming, or digital manufacturing workflows.
• Familiarity with electronic QMS systems (e.g., MasterControl, Greenlight Guru).
• Experience supporting FDA inspections or notified-body audits.

Skills

• Leadership and team development
• Root cause analysis and problem solving
• Strong documentation and organizational skills
• Decision-making in fast-paced environments
• Continuous improvement mindset
• High attention to detail and compliance focus

Work Environment

• Ability to work in manufacturing, cleanroom, and inspection areas.
• Ability to stand, walk, and lift up to 30–40 lbs as needed.
• Use of PPE as required (gloves, safety glasses, cleanroom attire).
• Occasional overtime during audits, investigations, or production surges.

Travel & Schedule

Travel is approximately 5% with overnight stays required. Standard workweek with occasional off-shift support.

Benefits

We offer a competitive base salary and benefits.