What are the responsibilities and job description for the Quality Manager position at G&H Orthodontics?
This role is responsible for utilizing an established Quality Management System (QMS) to identify opportunities to continuously improve our products and processes that ensure our customers’ success. The Quality Manager will oversee product quality assurance, quality system management, and manufacturing process excellence – with specific emphasis on verifications and validations, FDA/ supplier audits, vendor management, CAPAs, complaint handling and new product introduction and advancing continuous improvement efforts. This role is hands-on and critical to the daily and long-term operation of the manufacturing site. The Quality Manager will partner closely with Engineering and Manufacturing leadership.
Qualifications:- Bachelor’s degree in engineering or science or related discipline.
- 7 years of quality management experience in a manufacturing environment, preferably FDA-regulated.
- Experience managing both salaried and hourly (non-salaried) individuals is required.
- Lean Six Sigma Green or Black Belt certification preferred.
- Strong leadership and team development skills.
- Proficient in fishbone and other root cause analysis
- Excellent communication and presentation abilities.
- Experience with ISO standards, CAPA, validation, and change control.
- Proficient in Microsoft Office (Excel, Word, Outlook); experience with Minitab preferred.
- Fluent in English with strong written and verbal skills.
- Detail-oriented with strong organizational and project management capabilities.
- Ability to work independently and drive results in a fast-paced environment.