Senior Quality Control Lead — Medical Devices

Precision Optics; South Gardner (MA); On-site; USD 120,000 - 150,000; Full time

Job summary

Precision Optics in Gardner, MA seeks a Quality Control Manager to lead QC in a regulated medical device contract manufacturing setting. You will ensure compliance with FDA 21 CFR Part 820, ISO 13485, and customer requirements while directing QC personnel and continuous improvement initiatives.

Responsibilities include overseeing incoming, in-process, and final inspections, DHR reviews, calibration management, and audits. Strong leadership and documentation skills are essential.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or manufacturing.
• 5+ years in quality control/quality assurance in the medical device industry.
• 2–3 years of leadership or supervisory experience.
• Strong knowledge of FDA 21 CFR Part 820 and ISO 13485.

Responsibilities

• Oversee daily inspection, testing, documentation review, and release of materials and finished devices.
• Prioritize work and allocate resources to support production schedules while maintaining quality requirements.
• Develop and maintain QC procedures, work instructions, inspection methods, and acceptance criteria.
• Oversee DHR reviews for completeness, accuracy, traceability, signatures, approvals, and supporting evidence.
• Administer calibration program for inspection, measuring, and test equipment; ensure traceability.
• Identify, document, segregate, control, and disposition of nonconforming materials and products.
• Participate in CAPA, audits, and QMS improvements; support supplier quality activities.

Skills

Leadership

Documentation

Problem solving

Regulatory knowledge

Statistical methods

Education

Bachelor's degree in Engineering/Quality/Life Sciences

Tools

Gage R&R

Measurement systems

Job description

Precision Optics in Gardner, MA seeks a Quality Control Manager to lead QC in a regulated medical device contract manufacturing setting. You will ensure compliance with FDA 21 CFR Part 820, ISO 13485, and customer requirements while directing QC personnel and continuous improvement initiatives.

Responsibilities include overseeing incoming, in-process, and final inspections, DHR reviews, calibration management, and audits. Strong leadership and documentation skills are essential.