Quality Control Manager, Medical Devices & Compliance

Precision Optics Corporation; Gardner (MA); Presencial; USD 110.000 - 160.000; Jornada completa

Descripción de la vacante

Precision Optics Corporation in Gardner, MA seeks a Quality Control Manager to lead QC in a regulated Class II medical device contract manufacturing environment. You will ensure FDA 21 CFR Part 820 and ISO 13485 compliance, oversee inspection, release, DHR reviews, calibration, nonconforming material controls, and continuous improvement.

You will mentor QC staff, develop procedures, drive metrics, and partner with Manufacturing, Regulatory Affairs, and Quality Assurance to sustain product

Formación

• BS in Engineering, Quality, Life Sciences, Manufacturing, or related field.
• 5+ years in Quality Control, Quality Assurance, or Manufacturing Quality in the medical device industry.
• 2–3 years of leadership or supervisory experience.

Responsabilidades

• Lead daily QC inspection, testing, documentation review, and release of materials and finished devices.
• Develop and maintain QC procedures, work instructions, inspection methods, and acceptance criteria.
• Oversee DHR reviews, calibration management, nonconforming material disposition, CAPA participation, and audits.
• Mentor QC staff and drive continuous improvement across departments.

Conocimientos

Quality control

Leadership

Regulatory knowledge

Documentation

Problem solving

Communication

Educación

Bachelor’s degree in Engineering/Quality/Life Sciences

Herramientas

Gage R&R

MSA

Calibration systems

Descripción del empleo

Precision Optics Corporation in Gardner, MA seeks a Quality Control Manager to lead QC in a regulated Class II medical device contract manufacturing environment. You will ensure FDA 21 CFR Part 820 and ISO 13485 compliance, oversee inspection, release, DHR reviews, calibration, nonconforming material controls, and continuous improvement.

You will mentor QC staff, develop procedures, drive metrics, and partner with Manufacturing, Regulatory Affairs, and Quality Assurance to sustain product