Quality Engineer III – Injection Molding (Medical Device Manufacturing)

Confidential Recruiting Partners; Brooklyn Park (MN); On-site; USD 90,000 - 115,000; Full time

Job summary

Confidential Recruiting Partners is seeking a Quality Engineer III – Molding to provide senior-level quality engineering support in a regulated manufacturing environment. The role leads quality activities for injection molding, including PFMEA, CAPA, validation, metrology, and data-driven process improvement.

Onsite role with no visa sponsorship or relocation; collaborates with production to deliver robust inspection strategies and continuous improvement across molding processes and related

Qualifications

• Bachelor's degree in Mechanical, Industrial, or related field.
• 6+ years of engineering experience in a machining/manufacturing environment.
• Strong GD&T, blueprint interpretation, and dimensional inspection skills.
• Hands-on PFMEA, CAPA, DOE, capability studies, and data analysis.
• Proficiency with Minitab or equivalent statistical tools; ERP/quality systems.

Responsibilities

• Lead quality activities for molding operations and cross-functional teams.
• Conduct PFMEA, CAPA, and trend analysis; drive root-cause investigations.
• Develop inspection and control plans; maintain quality documentation.
• Support validation activities IQ/OQ/PQ and metrology programs.
• Audit compliance with ISO standards and internal procedures.

Skills

Minitab

GD&T

Blueprint reading

Dimensional inspection

Root cause analysis

DOE

CAPA

PFMEA

Statistical data analysis

Communication

Education

Bachelor's degree in Mechanical, Industrial, or related Engineering

Tools

ERP systems

Quality Management Software

Job description

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.