Quality Manufactuing Engineer - Aptyx

The Quality Engineer is responsible for ensuring the integrity and compliance of injection molding processes used in the production of medical devices. This role involves developing, implementing, and overseeing validation protocols to ensure that manufacturing processes meet regulatory requirements and quality standards.

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.

Qualifications:

Junior Quality Engineer

• Education:
  • Bachelor's degree in engineering, preferably in Mechanical, Industrial, or Plastics Engineering preferred.
• 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.

Quality Engineer

• Education:
  • Bachelor's degree in engineering, preferably in Mechanical, Industrial, or Plastics Engineering.
• Experience:
  • Minimum of 3-5 years of experience in a quality role within the medical device manufacturing industry, with significant experience in plastic injection molding.
• Knowledge:
  • In-depth understanding of quality assurance principles and methodologies.
  • Extensive knowledge of injection molding processes and equipment.
  • Familiarity with medical device regulations and standards, including ISO 13485 and FDA requirements.
• Skills:
  • Strong analytical and problem-solving skills.
  • Excellent attention to detail and organizational skills.
  • Proficiency in statistical analysis and quality management software.
  • Effective communication and leadership skills.
• Certifications:
  • Certification such as Certified Quality Engineer (CQE) from ASQ is highly desirable.

Senior Quality Engineer

• Education:
  • Bachelor's degree in engineering, preferably in Mechanical, Industrial, or Plastics Engineering. A master's degree is a plus.
• Experience:
  • Minimum of 5-7 years of experience in a quality role within the medical device manufacturing industry, with significant experience in plastic injection molding.
• Knowledge:
  • In-depth understanding of quality assurance principles and methodologies.
  • Extensive knowledge of injection molding processes and equipment.
  • Familiarity with medical device regulations and standards, including ISO 13485 and FDA requirements.
• Skills:
  • Strong analytical and problem-solving skills.
  • Excellent attention to detail and organizational skills.
  • Proficiency in statistical analysis and quality management software.
  • Effective communication and leadership skills.
• Certifications:
  • Certification such as Certified Quality Engineer (CQE) from ASQ is highly desirable.

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.