Quality Engineer Jobs

Position: Quality Engineer

Reports to: Quality Manager

The Company

With double-digit annual growth rate since our founding in 1998, we are continuing to expand our dynamic team. As a contract manufacturer for in-vitro diagnostics, we make sure great products get made. The Natech learning organization develops collaborative problem solvers who help our customers launch and scale new medical devices.

The Opportunity

As a technical leader and trusted advisor, clients will depend on you as their subject matter expert. You will use your quality control expertise, along with your understanding of the clients’ needs to guide the internal team on all areas relating to the long-term quality of their products and processes. You will inspire confidence, innovation, and excitement both inside and outside of the organization while providing guidance and mentorship to the Natech Team!

Key Responsibilities

• Tool Designer: Design, fabricate, and implement quality tooling for functional testing, inspection fixturing, and GO/NOGO gaging.
• Vision System Integrator: Create, update, and manage automated OGP Smartscope inspection routines using Zone3. Provide unwavering training and support to the team by debugging, modifying, and qualifying new and existing inspection routines.
• Quality Process Contributor: Support Quality Assurance in ensuring compliance to ISO9001 and ISO13485 standards through the creation, maintenance and audit of inspection records, establish statistical confidence through proven control plans, lead corrective & preventive action initiatives, manage rejection reporting and non-conforming material review, assist in design transitions from Engineering to Production, manage engineering change orders and requests, ensure organizational goals are continually met.
• Business Development Asset: Support relationships with prospective and existing clients, manage client driven corrective and preventative actions, support rectification of client concerns through extensive quality analysis, and provide internal clients with exceptional quality suggestions as it pertains to inspection, drawing and dimensional requirements.
• Quality Control Expert: Support enduring customer satisfaction through extreme quality. Lead the team in the creation and revision of inspection protocols and procedures, generate and implement part specific quality control plans, advise best metrology practices, perform FAIR on new and existing molds, support engineering development projects to ensure quality output, and routinely review production and quality for conformance.
• Continual Improvement Champion: Identify key areas & processes in need of improvement, voraciously research improvement options, identify the path, scope, and budget for the project, create a compelling Business Case for review with the Management Team, and drive projects to completion.
• Data Analyst: Perform process validation studies on new and existing molds and processes, analyze data to determine process capability, integrate inspection plans into IQMS SPC module for ERP traceability, and routinely perform gage R&R studies.

Qualifications

• Excellent computer literacy, including knowledge of shortcut keys.
• Proficiency with Solidworks in the creation of 3D part models, fixtures, and simple assemblies.
• Extreme attention to detail and organization, and an insatiable eagerness to learn and grow.
• Experience using OGP Vision Systems, QVI Zone3 Metrology software, or equivalent CMM technology.
• Strong understanding of GD&T, best measurement practices, and interpreting technical drawings.
• Ability to bend and lift up to 40 lbs., perform duties while seated or standing for prolonged periods and access and navigate the production facilities.
• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or equivalent.
• Proficiency in using mechanical inspection tools to measure and qualify molded parts.
• Ability to manage and inspire a diverse cross-functional team working on simultaneous projects in a fast-paced environment.
• Minimum of 5 years of engineering or manufacturing experience in a quality-oriented field.

Highly Desirable

• Working knowledge of ISO9001, ISO13485, and U.S. FDA Code of Federal Regulations - (CFR) Title 21 is a plus.
• Project management experience and ability to use Project Management software to plan, monitor and control activities.
• Proficiency in Spanish.

Salary Range:

$75,000 - $85,000 a year

Job Type:

Full-time

We are an Equal Opportunity Employer and do not discriminate on the basis of race, color, religion, age, gender, national origin, genetic information, sexual orientation, gender identity characteristics or expression, familial status, citizenship status, marital status, disability, veteran status, domestic violence victim status, height, weight or any other legally protected status, in any employment decisions, including, but not limited to, recruitment, hiring, compensation, training, apprenticeship, promotion, demotion, transfer, layoff, termination, and any other term and condition of employment. All employment-related decisions are based solely on relevant criteria, including training, experience, education, qualifications, abilities, and suitability.