Quality Assurance Manager

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

The Quality Assurance Manager leads all operational inspection and metrology activities at Lowell. The role oversees the Inspection Managers/Supervisors and CMM Supervisor, owns the calibration program, and serves as the senior technical authority on inspection methods, gauge selection, and metrology decisions for both released production and new product introduction (NPI) work.

This is a hands-on leadership role for a candidate who can interpret prints in accordance with ASME Y14.5, makes sound decisions about inspection approaches, and can clearly defend those decisions to engineers and customers. The ideal candidate has a strong track record of building inspection teams that deliver right-the-first-time results in a regulated environment.

About Lowell

Lowell is the premier partner for the development and production of technologically advanced, implantable medical devices for the cardiovascular, spine, trauma and extremities markets. We manufacture components and assemblies that save lives and improve quality of life.

Key Responsibilities

• Lead, develop, and coach direct reports mentioned above.
• Build technical depth and succession across the inspection and CMM functions
• Manage performance, hiring, and capacity planning across inspection and metrology staff
• Resolve cross-shift and cross-function escalations involving inspection authority

Inspection and Metrology Operations

• Own the operational execution of receiving, in-process, and final inspection on machined components and assemblies.
• Approve inspection methods, fixturing, and gauge selection for new and existing parts
• Lead resolution of measurement disputes with customers, suppliers, and internal engineering
• Ensure inspection capacity and throughput keep pace with production demand

CMM and Programming Oversight

• Provide technical direction to the CMM Supervisor on programming standards, probe selection, and measurement strategy
• Review and approve CMM programs for complex or critical features
• Drive consistency in CMM methodology across machines and operators

Calibration Program

• Own the operational calibration program: schedules, recall, vendor management, OOC investigation
• Partner with the Quality Systems Manager on calibration procedures and records as QMS documents

Quality System Participation

• Participate in MRB dispositions and provide technical judgment on nonconforming product
• Support CAPA investigations involving inspection escape, measurement system error, or operator method
• Represent inspection and metrology in BSI surveillance audits and FDA inspections
• Partner with the Quality Systems Manager on procedural changes affecting inspection execution

Customer and NPI Engagement

• Serve as the senior inspection voice in customer-facing technical discussions
• Partner with ME/QE on inspection method development for NPI parts
• Approve First Article Inspection (FAI) packages and PQ measurement submissions

Required Qualifications

• Bachelor’s degree in engineering, manufacturing technology, metrology, or a related technical field; equivalent experience will be considered.
• 10+ years of progressive experience in inspection and metrology for precision-machined components.
• 5+ years of people management experience, including leadership of managers or supervisors.
• Demonstrated technical depth in dimensional inspection, including GD&T, hard gauging, optical comparators, surface finish measurement, vision measurement, etc.
• Working knowledge of CMM operation and programming logic, with the ability to evaluate CMM strategy and probe selection.
• Fluency in print reading and GD&T interpretation in accordance with ASME Y14.5.
• Experience leading inspection teams in a regulated manufacturing environment, such as medical device or aerospace.
• Familiarity with ISO 13485 and 21 CFR 820 / QMSR requirements.
• Direct experience supporting third-party audits, including ISO, BSI, AS9100, or FDA inspections.
• Strong written and verbal communication skills, with the ability to defend technical positions to customers and regulators.

Preferred Qualifications

• Hands-on CMM/VMS programming experience with Zeiss Calypso, PC-DMIS, Zone3, or similar platforms.
• Medical device manufacturing experience, particularly with orthopedic or cardiovascular implants.
• ASQ certification, such as CQM/OE, CQE, or CMI.
• Six Sigma Green Belt or Black Belt certification.
• Experience with measurement systems analysis, including Gage R&R, bias, and linearity studies.
• Experience implementing or improving calibration programs.
• Lowell offers a competitive compensation and benefits package including Medical, Dental, PTO, Vision, Life Insurance, 401k Retirement Plan with 3% employer contribution, and Profit-Sharing plan.

If you are a highly motivated individual who takes pride in their work, we would love to hear from you.

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