Quality Engineer III – Injection Molding (Medical Device Manufacturing)

Our client is seeking a Quality Engineer III – Moldingto provide senior-level quality engineering support within a regulated manufacturing environment. This role leads quality activities for injection molding operations, including PFMEA, CAPA, validation, metrology, and data-driven process improvement. The engineer serves as a key quality partner to production teams and supports continuous improvement across molding processes and related manufacturing areas.

Onsite | No Visa Sponsorship | No Relocation

Responsibilities:

• Maintain an organized work area and support operational excellence initiatives.
• Participate in cross-functional projects, providing quality input and recommendations.
• Ensure adherence to quality systems, standard work, and documented procedures.
• Support and execute process, equipment, and metrology validation activities (IQ/OQ/PQ)
• Provide quality engineering support for molding operations and cross-functional manufacturing teams.
• Analyze production and quality data to identify improvement opportunities and drive corrective actions.
• Conduct internal audits, close findings, and support compliance with ISO and regulatory requirements.
• Mentor junior quality engineers and support quality inspectors in developing robust inspection strategies.
• Serve as a technical resource for GD&T, blueprint interpretation, metrology methods, and inspection equipment.
• Develop and maintain quality documentation, including inspection plans, control plans, PFMEAs, and discrepancy resolution records.
• Lead investigations into nonconformances, customer complaints, and process issues using root cause analysis, CAPA, and trend analysis.

Qualifications (Must-Haves)

• Proficiency with Minitab or equivalent statistical software.
• Experience with ERP and quality management systems.
• Strong communication, organization, and multitasking skills.
• Bachelor's degree in Mechanical, Industrial, or related Engineering discipline.
• 6+ years of engineering experience in a machining or manufacturing environment.
• Ability to work effectively in a fast-paced, cross-functional manufacturing environment.
• Advanced proficiency in GD&T, blueprint reading, and dimensional inspection methods.
• Hands-on experience with PFMEA, CAPA, DOE, capability studies, and quality data analysis.
• Strong knowledge of ISO-based quality systems, regulatory requirements, and industry standards.

Preferred Skills:

• Experience in injection molding quality engineering.
• Experience in medical device or other regulated manufacturing industries.
• Familiarity with scientific molding, decoupled molding, or advanced molding methodologies.

Work Environment:

• Onsite role in a manufacturing setting.
• Requires regular collaboration with production, engineering, quality, and operations teams.