Quality ManagerJob Summary: 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.
Essential Functions: - 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.
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.
Preferred but not required 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.
Competencies: - 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
Physical and Work Environment Requirements: - 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 & Benefits - Travel is approximately 5% with international overnight stays required
- We offer a competitive base salary and benefits.
- Standard workweek with occasional off-shift support.
