Senior Quality Engineer

Summary Of Position Mission

In this exciting role as a Senior Quality Engineer, you will have the primary focus on supporting new product development and production across the business. We are looking for an experienced senior QA engineer to oversee all aspects of product testing within the company. This includes developing test strategies, drawing up test documents, identifying faults, generating quality assurance standards for all products, and reviewing QA reports.

To ensure success, you should have extensive experience in analytics, high-level hands‑on problem‑solving skills, and the ability to project manage. A top‑notch senior QA engineer guarantees the smooth running of the QA department and ultimately customer satisfaction.

• Apply knowledge of Design Control principles and quality engineering to positively influence new product development efforts, including Voice of the Customer, establishing design inputs/outputs, Design Verification & Validation, Process Characterization & Validation, Component Qualification, and Risk.
• Actively represent the Quality Engineering function on product development teams.
• Hands‑on participant in early stages of product development, including physician interaction, component engineering, competitive product research, and prototype testing.
• Work with product engineers to help define the quality characteristics and validation criteria for components, subassemblies, and finished devices.
• Ensure product development activities are conducted in accordance with ISO and internal Quality System requirements.
• Drive predictive engineering methodology principles (DRM) incorporating reliability and capability analysis assessments in design and manufacturing processes.
• Provide QA support to product development teams, resolving problems, defects, and other issues to ensure products meet specifications.
• Document results and offer observations or improvements after analysis of test results and overall product quality.
• Support, design, develop, and enhance test processes and reporting for QA.
• Establish quality performance metrics to prevent issues proactively.
• Manage testing efforts across projects and tasks.
• Mentor and provide training assistance to QA and QC personnel.
• Develop and maintain standards and methods for inspection, testing, and evaluation.
• Investigate product quality problems, determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate the cause.
• Perform process capability studies or special studies necessary to increase control and decrease total quality costs.
• Plan and oversee the analysis, inspection, design, and test of products to assure quality of parts and products.
• Perform quality engineering review of design documentation for compliance with stated requirements, including vendor quality manuals and company quality records.
• Utilize test equipment such as calipers, micrometers, Rockwell testers, surface plates, optical comparators, and CMM.
• Have a clear understanding of GD&T.
• Assist in maintaining ISO 9001 compliance.
• Work closely with manufacturing and warehouse supervisors to support quality inspection requirements.
• Lead the Corrective Action Program.
• Ensure the successful deployment of high‑quality, repeatable products into the market.
• Other duties will be assigned as required.

• BS degree in Quality or Mechanical Engineering required.
• Minimum of 7 years of quality engineering experience in a manufacturing environment.
• Excellent technical background with a track record of problem solving and process development.
• Experience in firearm production, tooling and machining highly preferred.
• General knowledge of CAD and CMM software packages.
• Experience with Master Cam, Catia V5, and Solid Works is a plus.
• Managerial experience preferred.
• High‑level analytical skills.
• Advanced written and verbal communication skills.
• Critical thinker.
• Ability to project manage.
• Proficient in MS Office software.
• Detail oriented.

Work is normally performed in a climate‑controlled office environment and throughout a heated manufacturing and warehouse facility. Exposure to extreme heat/cold, poor ventilation, fumes, and gases is very limited. Noise level is moderate and includes light manufacturing, shipping and receiving, and normal office equipment. No known environmental hazards are encountered in normal performance of job duties.

• Be able to lift objects up to 35 lbs.
• Ability to move objects as requested and necessary.
• Be able to lift, push, and pull objects as necessary.
• May be required to stand and walk throughout the workday.
• May be required to operate small hand tools.
• Occasionally required to bend, stoop, kneel, and crouch.