Quality Systems Manager – Medical Device Compliance

100Hires, Inc.; Attleboro (MA); On-site; USD 110,000 - 160,000; Full time

Job summary

100Hires, Inc. is seeking a Quality Systems Manager to lead the end-to-end Quality Management System aligned to ISO 13485 and ISO 9001, with FDA and ITAR compliance.

You will oversee metrology, CAPA, audits, supplier quality, and quality planning for precision machined medical components. The role requires hands-on metrology expertise, strong leadership, and collaboration across manufacturing, engineering, suppliers, and customers to reduce defects and support product launches and steady-state

Qualifications

• Experience with ISO 13485, ISO 9001, FDA-regulated processes.
• Experience in regulated manufacturing environments such as medical devices, aerospace, or defense.
• Hands-on metrology and calibration experience.
• Strong leadership and cross-functional problem solving.

Responsibilities

• End-to-end stewardship of the Quality Management System aligned to ISO 13485 and ISO 9001, and compliant with FDA, ITAR, customer specifications, and internal procedures.
• Quality assurance for precision machined medical components: inspection planning, process controls, disposition of nonconforming material, CAPA, audits, supplier quality, and customer-specific needs.
• Cross-functional problem solving with manufacturing, engineering, suppliers, and customers to resolve issues and drive continuous improvement.
• Audit readiness and support for ISO, customer, regulatory, supplier, and ITAR-related assessments.
• Ownership of metrology and measurement systems: gage calibration, dimensional inspection, GD&T, and use of CMM or optical methods.
• Data-driven improvement using statistical methods, capability analysis, and MSA to improve quality metrics.
• People leadership: train and develop Quality team members to meet compliance and manufacturing requirements.

Skills

ISO 13485

ISO 9001

ITAR

GD&T interpretation

Metrology expertise

Calibration

CMM/Optical inspection

MSA (Measurement Systems Analysis)

Data-driven improvement

Leadership

Cross-functional collaboration

Auditing

Quality planning

Education

Bachelor’s degree (Quality/Engineering/Manufacturing/Operations)

Tools

CMM

Optical inspection

Job description

100Hires, Inc. is seeking a Quality Systems Manager to lead the end-to-end Quality Management System aligned to ISO 13485 and ISO 9001, with FDA and ITAR compliance.

You will oversee metrology, CAPA, audits, supplier quality, and quality planning for precision machined medical components. The role requires hands-on metrology expertise, strong leadership, and collaboration across manufacturing, engineering, suppliers, and customers to reduce defects and support product launches and steady-state