Quality Engineer

POSITION PURPOSE:

This is a hands-on position that will support the customer experience (and drive sales growth) by working to mitigate risk through detection and prevention at both a product and systems level. The position requires a solid understanding of Structured Problem Solving and Quality Control tools and concepts and will help implement and continuously improve those practices as well as the ability to balance priorities, drive accountability and action and communicate in a detailed and real-time manner. Sphere of interaction regularly includes team and front-line employees, at times customers, suppliers and cross-functional roles or leadership.

ESSENTIAL FUNCTIONS AND BASIC DUTIES:

Cross-Functional
• Coordinate and communicate plans and activities to drive a "team" approach where needed.
• Provide technical assistance as it relates to process capability, new product introduction, and defect detection or prevention.


Customer
• Serve as site liaison to customers regarding quality problems, concerns


Fill out and submit waivers and deviations to customers
• Analyze failure to meet requirement, determine corrective and preventative action (CPA) and use a structured problem-solving template such as 8D
• Create, update, and maintain process Control Plans and pFMEA's as needed
• Develop and recommend inspection and sampling techniques or other risk mitigation for new customers and parts as needed. Recommend and facilitate optimization for existing processes

Supplier
• Ensure timely resolution of failure, corrective, and preventative actions
• Manage performance and coordinate visits as needed
• Provide technical assistance when questions or deviations arise


Standards
• Support creation and implementation of quality procedures, specifications, standards, data collection and metrics to ensure products meet or exceed requirements
• Conform to the company quality management system as documented.

Improvement
• Review and analyze information and facilitate cross-functional efforts to systematically mitigate risk in "problem areas"
• Assist in supporting procedures and modifications in QMS, product or quality standards as needed
• Participate in projects to eliminate scrap, reduce rework operations, and optimize inspection process and procedures


Own customer, internal, and supplier quality issue reports from initiation to closure.

Performs related work as apparent or assigned. Assist Quality Manager as required.

QUALIFICATIONS

EDUCATION/EXPERIENCE: Four-year degree in a technical field or 2-year degree with 2 years' experience

• Familiarity and exposure to regulated environments and requirements such as FDA, ISO and AS9100
• Familiarity with SPC, GD&T, FMEA, DOE, Control Plans, qualification processes like IQ/OQ/PQs
• Understanding of manufacturing and assembly methods such as fixtures, tooling, and fabrication & gaging methodology and metrology
• Ability to transform raw data into conclusions and recommendations a plus
• Skilled in Excel and other basic MS Office applications

SKILLS and ABILITIES:

• Influence and effectively communicate (written and verbally) with a wide variety of personnel and roles. Excellent internal & external customer services skills.
• Conduct structured problem solving, manage time, prioritize competing demands, and escalate as needed
• Quickly learn new concepts, software, interfaces, and tools
• Translate minimal direction into action, work independently, adapt to change, be curious and open-minded

OTHER REQUIREMENTS:

PHYSICAL STRENGTH: No heavy lifting required.

LANGUAGE ABILITY: Able to read and follow instructions in English.