Quality Engineer - 1st Shift (7:00 AM - 3:30 PM; Monday - Friday)

Shift: 1st Shift (7:00 AM - 3:30 PM; Monday - Friday)

Position Purpose: The Quality Engineer supports product and process quality throughout the product lifecycle, with a strong focus on new product introduction (NPI), metrology, measurement systems, validation, and continuous improvement. Partnering closely with customers and collaborating across Engineering, Manufacturing, and Suppliers, this role develops and implements inspection and validation processes, analyzes quality data, and leads corrective action initiatives to ensure products consistently meet customer requirements, regulatory expectations, and quality standards.

Essential Responsibilities:

• Develop and maintain quality plans, inspection procedures, validation protocols, and quality documentation for new and existing products.
• Lead quality activities for New Product Introduction (NPI), including First Article Inspection (FAI), process validation (IQ, OQ, PQ), capability studies, PPAP generation, Process Flow, PFMEA and control plans.
• Develop, validate, and maintain measurement systems to ensure accurate and repeatable inspection results.
• Perform Measurement System Analysis (MSA), including Gage R&R studies, and support calibration of inspection and test equipment.
• Interpret engineering drawings and GD&T to establish effective inspection methods using Smartscope CMMs and other precision measurement equipment.
• Investigate customer complaints, internal nonconformances, and supplier quality issues; lead root cause analysis and corrective actions (8D, 3L5Y, CAR, MRB).
• Monitor quality performance and analyze data using statistical methods (SPC) to identify trends and drive process improvements.
• Collaborate with Engineering, Manufacturing, Suppliers and Customers to ensure quality requirements are incorporated throughout product development and production.
• Conduct internal quality audits, support customer audits, and maintain quality records to ensure compliance with ISO 9001:2015.
• Facilitate training on quality requirements, inspection methods, and best practices.
• Support continuous improvement initiatives to enhance product quality, manufacturing efficiency, and customer satisfaction.
• Perform other duties as assigned.

Qualifications/Experience:

Required

• Associates or Bachelor’s degree in Engineering, Quality, Manufacturing, or a related technical field (or equivalent experience).
• Quality engineering experience in a manufacturing environment.
• Working knowledge of ISO.
• Experience with NPI, First Article Inspection (FAI), PPAP, capability studies, and validation activities.
• Strong understanding of metrology, Measurement System Analysis (MSA), calibration, and precision measurement techniques.
• Ability to interpret engineering drawings and GD&T.
• Strong analytical, problem-solving, and communication skills.
• Computer proficiency.

Desired

• Plastic Injection Molding Industry Experience
• Delmiaworks (IQMS) ERP System Experience