Global Quality Engineer - Remote

The Global Quality Engineer (GQE) is responsible for preparing and compiling documentation to provide evidence of product / process qualification (e.g., PPAP, FAI, or internal). The GQE organizes a centralized repository for these documents per the APTYX Gate System and delivers the required documentation to customers to meet qualification requirements. Additionally, the GQE authors standardized summary reports related to product and process qualifications.

Essential Job Functions

• Validation Protocol and Customer Requirements :

Develops and ensures thoroughness in validation protocols by integrating customer-specific product / process qualification requirements and APTYX Advanced Quality Disciplines.

Ensures accuracy and reliability through Gauge R&R studies, calibration, and other methodologies to build customer confidence.

Trains team members on part assessment techniques, covering dimensional, structural, and aesthetic attributes.

Prepares and schedules PQ activities, ensuring team alignment with company expectations.

Leads process validations, including protocol development, execution, and capability studies, as part of the APTYX NPI program.

Oversees laboratory measurements and ensures methodologies are transferable to production-quality inspections.

Adheres to GMP, EPA, OSHA / OSHA, and company policies while promoting a positive and safe work environment.

Interfaces with Engineering and Manufacturing teams to ensure smooth product transfers to production.

Contributes to new product development and quality improvement initiatives.

Employment and Educational Requirements

Bachelor's degree in engineering science (or equivalent education / experience).

5-7 years of experience in medical device manufacturing (highly preferred).

Geometric Dimensioning & Tolerancing (GD&T) training.

Self-motivated, organized, and able to adapt to fast-paced environments.

Ability to travel to APTYX locations as needed.

Working Conditions