Senior QA & Metrology Leader - Medical Devices

Lowell Inc.; Lowell (MA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

PTO

Vision insurance

Life Insurance

401k Retirement Plan with employer 3%

Profit-Sharing plan

Job summary

Lowell is seeking a Quality Assurance Manager to lead inspection and metrology operations for machined components and assemblies, including CMM and calibration programs. You will mentor Inspection Managers/Supervisors, own calibration procedures, and ensure compliance for FDA and ISO audits in a regulated medical device environment.

The role requires deep GD&T knowledge, print interpretation per ASME Y14.5, and a proven track record building high-performance teams that deliver first-pass quality

Qualifications

• Bachelor’s degree in engineering, manufacturing technology, metrology, or related field; equivalent experience considered.
• 10+ years in inspection/metrology for precision-machined parts.
• 5+ years people management experience leading managers or supervisors.
• Strong GD&T and dimensional inspection expertise.
• CMM operation and programming knowledge.
• Fluent GD&T interpretation per ASME Y14.5.
• Experience in regulated manufacturing (medical device or aerospace).
• Familiarity with ISO 13485 and 21 CFR 820 or QMSR requirements.
• Experience supporting third-party audits (ISO, BSI, AS9100, FDA).
• Strong written and verbal communication with customers/regulators.

Responsibilities

• Lead, develop, and coach inspection and metrology teams.
• Oversee inspection methods, fixturing, and gauge selection.
• Ensure capacity and throughput align with production demand.
• Own calibration program: schedules, recalls, vendor management.
• Represent inspection in MRB, CAPA, and audits.
• Collaborate with ME/QE on NPI inspection methods.

Skills

Leadership

GD&T

CMM operation

ASME Y14.5

QC strategy

Regulatory knowledge

Communication

Education

Bachelor’s degree in engineering

Tools

Zeiss Calypso

PC-DMIS

Zone3

Job description

Lowell is seeking a Quality Assurance Manager to lead inspection and metrology operations for machined components and assemblies, including CMM and calibration programs. You will mentor Inspection Managers/Supervisors, own calibration procedures, and ensure compliance for FDA and ISO audits in a regulated medical device environment.

The role requires deep GD&T knowledge, print interpretation per ASME Y14.5, and a proven track record building high-performance teams that deliver first-pass quality