Quality Systems Manager — Medical Precision Machining

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

About the rolePicture a typical morning: you review capability studies and MSA dashboards, scan open CAPAs, and triage a supplier nonconformance while preparing the team for a customer audit. Before lunch, you walk the floor to verify process controls on a new precision-machined medical component and consult on a tricky GD&T callout. In the afternoon, you close the loop on inspection planning for a product launch and sign off on validation records. That blend of rigor, coaching, and hands-on problem solving is the heartbeat of this Quality Systems Manager role.What you will leadEnd-to-end stewardship of the Quality Management System aligned to ISO 13485 and ISO 9001, and compliant with FDA regulations, ITAR requirements, customer specifications, and internal procedures.Quality assurance for precision machined medical components: inspection planning, process controls, disposition of nonconforming material, CAPA, internal and external audits, supplier quality, and customer-specific quality needs.Cross-functional problem solving with manufacturing, engineering, suppliers, and customers to resolve issues, reduce defects, improve processes, and support both product launches and steady-state production.Audit readiness and support for ISO, customer, regulatory, supplier, and ITAR-related assessments.Ownership of metrology and measurement systems: gage calibration, dimensional inspection, blueprint interpretation, GD&T, and use of CMM or optical inspection methods.Formal review and approval of quality documentation including inspection and control plans, work instructions, validation records, first article inspections, and engineering change-related quality updates.Data-driven improvement using statistical methods, capability analysis, and measurement system analysis to drive measurable gains in quality performance.People leadership: manage, train, and develop Quality team members to elevate capability and meet compliance and manufacturing requirements.What you bringDeep working knowledge of ISO 13485, ISO 9001, ITAR, applicable FDA regulations, customer requirements, and documentation practices for regulated manufacturing.Background in precision machining and experience in regulated environments such as medical devices, aerospace, or defense.Hands-on metrology expertise, including calibration, dimensional inspection, blueprint reading, GD&T interpretation, and use of CMM or optical systems; strong grasp of MSA principles.Strength in team leadership, customer and auditor communication, structured problem solving, and using quality data to drive continuous improvement.Core competencies: accountability, collaboration, effective communication, customer focus, decision quality, process improvement, and results orientation.Education and experienceBachelor’s degree in Quality, Engineering, Manufacturing, Operations, or a related technical field preferred; equivalent experience considered.5+ years of progressive quality experience within precision machining, medical device, aerospace, defense, or similarly regulated manufacturing.Proficiency with ISO 13485, ISO 9001, FDA-regulated processes, ITAR-controlled work, audits, supplier quality, CAPA, metrology, calibration, dimensional inspection, print reading, GD&T, and quality planning.Comfort with Microsoft Office and fluency with quality management, calibration, inspection, data analysis, and enterprise systems.