Quality Manufacturing Engineer

4 days ago

Torrington, Connecticut, United States Aptyx Full time
Job Summary

Aptyx is seeking a highly skilled Quality Manufacturing Engineer to join our team. As a Quality Manufacturing Engineer, you will be responsible for ensuring the integrity and compliance of injection molding processes used in the production of medical devices.

Key Responsibilities
  • Validation Planning:
    • Develop and execute validation plans and protocols for injection molding processes.
    • Prepare and review validation documentation, including Validation Master Plans (VMP), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Process Validation:
    • Lead and manage process validation activities to ensure that injection molding processes are consistent, reproducible, and capable of producing products that meet specifications.
    • Analyze and interpret data from validation tests and experiments, identifying trends and potential issues.
  • Regulatory Compliance:
    • Ensure that all validation activities comply with FDA regulations, ISO standards, and other relevant industry standards.
    • Prepare and review validation reports and ensure proper documentation for regulatory submissions and audits.
  • Continuous Improvement:
    • Collaborate with engineering and production teams to identify and implement process improvements.
    • Conduct root cause analysis and corrective actions for process deviations and non-conformances.
  • Cross-Functional Collaboration:
    • Work closely with design engineers, production staff, and quality assurance teams to ensure seamless integration of validation processes into the manufacturing workflow.
    • Provide training and support to team members on validation procedures and best practices.
  • Equipment and Tooling:
    • Oversee the validation of injection molding equipment and tooling, ensuring they are calibrated and maintained according to standards.
    • Evaluate new equipment and tooling to ensure compatibility with validation requirements.
Requirements
  • Education:
    • Bachelor's degree in engineering, preferably in Mechanical, Industrial, or Plastics Engineering.
  • Experience:
    • Entry-level position: previous internship or co-op experience in a quality role within the medical device manufacturing industry, particularly in plastics injection molding, is a plus.
  • Knowledge:
    • Basic understanding of quality assurance principles and methodologies.
    • Familiarity with injection molding processes and equipment.
    • Knowledge of medical device regulations and standards, such as ISO 13485 and FDA requirements.
  • Skills:
    • Strong analytical and problem-solving skills.
    • Excellent attention to detail and organizational skills.
    • Proficiency in Microsoft Office Suite and quality management software.
    • Effective communication and interpersonal skills.
  • Certifications:
    • Certification such as Certified Quality Engineer (CQE) from ASQ is a plus but not required.
Physical Requirements
  • Ability to stand or walk for extended periods.
  • Occasionally lift and move objects up to 25 pounds.
  • Work in a manufacturing environment with exposure to noise, heat, and other elements.
Work Environment
  • Manufacturing floor and office environment.
  • Fast-paced and deadline-driven setting.

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