Our client is seeking a Quality Engineer III – Molding to 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.
