Senior Quality Engineer

TOMZ Corporation; Big Lake (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

TOMZ Corporation in Minnesota seeks a senior Quality Engineer to lead NPI quality initiatives, develop robust inspection plans, and mentor cross-functional teams. You will drive CAPA actions, oversee metrology programs (CMM/vision systems), and ensure GMP/GDT compliance while coordinating with customers.

Ideal candidates have 7+ years in regulated manufacturing, ASQ CQE/CRE, and strong statistical methods experience, with a background in medical device contexts.

Qualifications

• Regulated manufacturing industry experience in medical device sectors preferred.
• Experience leading programs or customer-facing projects and mentoring juniors.
• Ability to work in a fast-paced environment and self-start.

Responsibilities

• Author and execute Quality Plans, Control Plans, and Master Validation Plans for New Product Introduction.
• Manage risk files with cross-functional teams and customers.
• Lead inspection planning and process controls, including first article and production visual standards.
• Support Gage calibration review, management, and evaluation.
• Apply CAPA methodologies to resolve quality issues.
• Interface with customers and ensure timely deliverables.

Skills

Lead on a Program

Mentoring junior associate

Statistics techniques

GD&T

Process validation

Metrology

CMM programming

Vision System programming

ASQ CQE or CRE

Six Sigma Green or Black belt

DMIS programming certifications

MS Office (Visio, Project, Outlook, Wd

Education

Bachelor's degree in Engineering, Manufacturing, or Business

Engineering degree with 7+ years of manufacturing quality experience (advanced metrology including CMM/ Vision System)

Tools

Solid Works

Unigraphics

Mastercam

Solid Edge

DMIS programming

Job description

Join our team in Big Lake!!

Summary Of Position

Reporting to the Quality Engineering Manager this position will be responsible for the activities associated with Quality of commercial product and successful transfer of Development programs to standard production, through leadership, coaching and technical guidance of cross-functional Engineering teams. This role will be expected to provide input on, and contribute to, development and implementation of Quality System improvement strategies and approaches. Additionally, this role will serve as a critical team member for activities associated with Quality Control and Assurance during New Product Introduction activities.

Essential Functions

• Author and execute Manufacturing Quality Plans, Control Plans and Master Validation Plans to support New Product Introduction.
• Controls the development and updates of Risk Management files in cooperation with cross-functional engineering teams, operations, and customers.
• Authors Inspection Plans and defines process controls.
• Subject Matter expertise of precision measuring instruments and their application, including but not limited to, calipers, micrometers, depth gages, indicators, and plug and thread Go/No Go gages.
• Execution and evaluation of Test Method Validations.
• Creation of production visual standards and standardized acceptance criteria for TOMZ’s manufacturing processes.
• Review and disposition non-conformities utilizing MRB/NCR process.
• Performs process qualifications, analyzes data and initiates corrections or corrective actions as required
• Provides hands-on directions for executing Incoming, In-Process and Final Product Inspection plans.
• Support First Article Inspections.
• Support Gage calibration review, management, execution and evaluation.
• Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues through the CAPA process.
• Interfaces with the customer and meets all defined deliverables.
• Support the tracking and reporting of inspection data, including but not limited to rejection rates, defect modes and process trends across customers/product families.
• Generate ECOs for the release of Quality Engineering documentation.
• Defines and Measures KPI’s for New Product Introduction.
• Supports the procurement and qualification of capital equipment.
• Operates and programs advanced measurement equipment including Vision Systems and CMMs.
• Adhere to the TOMZ Quality Management System.
• Perform other duties as assigned.

Qualifications

• Regulated manufacturing industry experience preferably Class I, II and/or III Medical Device manufacturing experience (exp: Aerospace, Defense, Pharmaceutical, etc.).
• Prior experience as a Lead on a Program or with a customer. Prior experience mentoring a junior associate.
• Demonstrated self-starter with ability to work in a fast-paced environment.
• Competency with Microsoft Office (Visio, Project, Outlook, Word, Excel, and PowerPoint).
• Strong verbal and technical writing capabilities (English language).
• Expertise is statistical techniques, GD&T, process validation, and Metrology.
• Demonstrated ability to work in and lead teams through large scale projects.

Education

• Bachelor's or higher degree in Engineering, Manufacturing, or Business discipline or equivalent of directly transferable industry work experience.
• Engineering degree and 7+ years of manufacturing quality experience including advanced metrology experience including CMM and/or Vision System programming. (10+ years of experience in Quality Engineering or similar discipline will be considered in lieu of a degree

Experience

• Minimum of 7+ years’ experience in a regulated manufacturing environment.
• Prior experience as a Lead on a Program or with a customer. Prior experience mentoring a junior associate.

Preferred Skills

• ASQ CQE or CRE.
• Expertise in 3D modeling Solid Works, Unigraphics, Mastercam, Solid Edge, etc.
• Six Sigma Green or Black belt.
• Certifications in DMIS programming are preferred.
• Knowledge and experience with external standards: ISO 9000/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints).

Travel Requirements

• Travel outside the workplace is possible for up to 10% of the year.
• Travel may include multiple overnight stays and may occasionally require weekend commitments.

Physical Requirements

• Ability to bend, stoop, squat, kneel, and lift up to 50 pounds. Team lift or mechanical assistance required for objects over 50 pounds.
• Ability to sit for prolonged periods.
• Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials. Personal protective equipment (PPE) such as safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required.
• Perform keyboard entries with frequent operation of a computer.