Quality Engineering Technician

Wynen's; Lakewood Township (NJ); On-site; USD 60,000 - 80,000; Full time

Job summary

Wynen's is seeking a Quality Engineering Associate to support a medical device manufacturing environment. You will assist with investigations, calibration, documentation, corrective actions, and continuous improvement initiatives to ensure product quality and compliance.

The role involves performing validation activities, Gage R&R testing, data analysis, CMM programming support, and development of SPC templates while applying GMP/GDP and GD&T principles in blueprints and controlled documentation.

Qualifications

• Knowledge of medical device quality requirements, including GMP/GDP.
• Proficiency in GD&T and blueprint interpretation.
• Experience with calibration, validation, and gage R&R data analysis.
• Familiarity with CMM programming and SPC template creation.

Responsibilities

• Execute validation protocols and support quality system activities.
• Conduct Gage R&R testing and perform data analysis.
• Assist with CMM programming and development of SPC templates.
• Apply strong understanding of GMP, GDP, and controlled documentation practices.
• Interpret blueprints and apply GD&T principles.

Skills

Investigations

Calibration

Documentation

Corrective actions

Continuous improvement

GD&T

Tools

CMM programming

SPC templates

Gage R&R data analysis

Job description

Quality Engineering Associate (Medical Device Manufacturing)

Support quality engineers in a medical device manufacturing environment by performing investigations, calibration, documentation, corrective actions, and continuous improvement activities.

Key Duties Include

• Execute validation protocols and support quality system activities.
• Conduct Gage R&R testing and perform data analysis.
• Assist with CMM programming and development of SPC templates.
• Apply strong understanding of GMP, GDP, and controlled documentation practices.
• Interpret blueprints and apply GD&T principles.

Qualifications & Skills

• Knowledge of medical device quality requirements, including GMP/GDP.
• Proficiency in GD&T and blueprint interpretation.
• Experience with calibration, validation, and gage R&R data analysis.
• Familiarity with CMM programming and SPC template creation.