Global Quality Engineer - Remote - Aptyx

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

1. 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.
2. Measurement System Accuracy:
   • Ensures accuracy and reliability through Gauge R&R studies, calibration, and other methodologies to build customer confidence.
   • Documents measurement techniques and provides detailed gauge instructions and standard operating procedures (SOPs).
3. Training and Oversight:
   • Trains team members on part assessment techniques, covering dimensional, structural, and aesthetic attributes.
4. Process Qualification (PQ):
   • Prepares and schedules PQ activities, ensuring team alignment with company expectations.
   • Develops sampling plans for dimensional, structural, and aesthetic attributes aligned with validation protocols.
   • Provides production teams with necessary PQ documents, including setup sheets, sample marking strategies, control/reaction plans, and workmanship standards.
5. Process Validation Management:
   • Leads process validations, including protocol development, execution, and capability studies, as part of the APTYX NPI program.
6. Laboratory and Inspection Support:
   • Oversees laboratory measurements and ensures methodologies are transferable to production-quality inspections.
7. Regulatory and Safety Compliance:
   • Adheres to GMP, EPA, OSHA/OSHA, and company policies while promoting a positive and safe work environment.
   • Treats safety as a priority by following established policies and procedures.
8. Collaboration and Communication:
   • Interfaces with Engineering and Manufacturing teams to ensure smooth product transfers to production.
   • Creates clear, standardized reports and maintains open communication with customers and internal teams.
9. Continuous Improvement and Development:
   • Contributes to new product development and quality improvement initiatives.
   • Assists in developing detailed process models, workflows, and manufacturing descriptions.

Employment and Educational Requirements

• Education:
  • Bachelor's degree in engineering science (or equivalent education/experience).
• Experience:
  • 5-7 years of experience in medical device manufacturing (highly preferred).
  • Practical experience with extrusion and injection molding (preferred).
  • Proficiency in cGMP and ISO quality systems.
• Skills and Certifications:
  • Geometric Dimensioning & Tolerancing (GD&T) training.
  • Measurement System Analysis (MSA) expertise.
  • Strong skills in MS Office, Excel, Project, and statistical software (e.g., Minitab).
  • CAD/SolidWorks proficiency.
  • Proven problem-solving and data analysis skills.
  • Knowledge of statistical and mathematical functions relevant to quality and process analysis.
  • Excellent written and verbal communication skills in English.
• Attributes:
  • Self-motivated, organized, and able to adapt to fast-paced environments.
  • Effective collaborator and independent problem solver.
• Travel:
  • Ability to travel to APTYX locations as needed.

Working Conditions

• Primarily performed in a well-lit, climate-controlled office environment.
• Tasks may involve working in controlled environments requiring hairnets, smocks, or personal protective equipment.