Quality Assurance Manager

Position Overview

The Quality Assurance Manager will lead all operational aspects of inspection and metrology at Lowell Inc., overseeing Inspection Managers, Supervisors, and the CMM Supervisor, while managing the calibration program. This role acts as the senior technical authority on inspection methodologies, gauge choices, and metrology decisions for both existing production and new product introduction efforts. The role demands hands-on leadership with expertise in interpreting mechanical prints per ASME Y14.5 standards, making well-founded inspection decisions, and confidently communicating these to engineers and customers.

Key Duties

• Lead, mentor, and develop direct reports including inspection and CMM supervisors.
• Build technical expertise and succession planning within inspection and metrology teams.
• Manage team performance, hiring, and capacity planning.
• Resolve escalations spanning shifts and functions related to inspection authority.
• Oversee all inspection activities: receiving, in-process, and final inspection for machined parts and assemblies.
• Approve inspection methods, fixtures, and gauge selections for both new and existing components.
• Lead resolution of measurement disagreements involving customers, suppliers, and internal engineering.
• Ensure inspection throughput aligns with production demands.
• Provide technical leadership to CMM Supervisor on programming standards, probe selection, and measurement strategies.
• Review and approve complex or critical CMM programs to maintain consistent methodology.
• Manage calibration program including scheduling, vendor management, out-of-calibration investigations, and partnership with Quality Systems Manager on calibration procedures.
• Participate in Material Review Board dispositions and provide expert judgment on nonconforming products.
• Support CAPA investigations related to inspection escapes, measurement system errors, or operator methods.
• Represent inspection and metrology during audits such as BSI and FDA inspections.
• Collaborate on procedural changes affecting the execution of inspections.
• Act as senior inspection technical liaison in customer discussions.
• Work closely with Manufacturing and Quality Engineering on inspection methods for new product introductions.
• Approve First Article Inspection packages and product qualification measurement submissions.

Required Qualifications

• Bachelor's degree or equivalent experience in engineering, manufacturing technology, metrology, or related technical disciplines.
• Over 10 years of progressive experience in inspection and metrology of precision-machined components.
• More than 5 years of leadership experience managing supervisors or managers.
• Strong technical proficiency in dimensional inspection, including GD&T, hard gauging, optical comparators, surface finish and vision measurement.
• Working knowledge of coordinate measuring machine (CMM) operation and programming logic with ability to assess measurement strategy and probe selections.
• Fluent in interpreting mechanical prints and geometric dimensioning per ASME Y14.5 standards.
• Experience leading inspection teams within regulated manufacturing sectors such as medical devices or aerospace.
• Familiar with ISO 13485 and 21 CFR 820 / QMSR regulatory requirements.
• Experience supporting third-party ISO, BSI, AS9100, and FDA audits.
• Excellent written and oral communication skills capable of justifying technical positions to customers and regulators.

Preferred Qualifications

• Practical programming experience with CMM or vision measurement systems using Zeiss Calypso, PC-DMIS, Zone3, or similar software.
• Medical device manufacturing exposure, especially orthopedic or cardiovascular implants.
• Relevant ASQ certifications such as CQM/OE, CQE, or CMI.
• Lean Six Sigma Green or Black Belt certification.
• Experience with measurement systems analysis including Gage R&R, bias, and linearity studies.
• Experience developing or enhancing calibration programs.

Benefits

• Competitive salary and benefits package including medical, dental, vision, life insurance, and paid time off.
• 401(k) retirement plan with 3% employer match and profit-sharing plan.

Company Profile

Lowell Inc. specializes in precision machining of complex implants and instruments for the medical device industry, manufacturing critical components and orthopedic implants that enhance quality of life. The company is committed to leveraging automation to maintain industry-leading manufacturing capabilities.