Key Responsibilities:

1.      Quality Assurance:

1. • Develop, implement, and maintain quality assurance policies and procedures to ensure product quality and compliance.
   • Conduct inspections of raw materials, in-process products, and finished goods to verify adherence to quality standards.

2.      Regulatory Compliance:

1. • Ensure that all products and processes comply with relevant medical device regulations and standards, such as ISO 13485 and FDA requirements.
   • Prepare and manage documentation for regulatory submissions and audits.

3.      Process Monitoring and Improvement:

1. • Monitor injection molding processes to ensure consistent product quality.
   • Identify areas for process improvement and lead initiatives to enhance product quality and manufacturing efficiency.

4.      Data Collection and Analysis:

1. • Collect and analyze data on product quality and process performance.
   • Prepare reports on quality metrics and trends to inform decision-making.

5.      Problem Solving and Root Cause Analysis:

1. • Lead root cause analysis and corrective action activities for non-conforming products.
   • Collaborate with production, engineering, and R&D teams to implement effective corrective and preventive actions.

6.      Supplier Quality Management:

1. • Evaluate supplier quality performance and conduct supplier audits.
   • Work with suppliers to resolve quality issues and ensure the supply of high-quality materials.

7.      Customer Interaction:

1. • Address customer complaints and quality concerns.
   • Support customer audits and visits by providing necessary documentation and information.

8.      Continuous Improvement:

1. • Drive continuous improvement initiatives aimed at enhancing product quality, reducing waste, and improving efficiency.
   • Participate in and lead cross-functional quality improvement teams.

9.      Training and Development:

1. • Mentor and train quality control personnel and junior quality engineers.
   • Conduct quality-related training programs for manufacturing and other relevant staff.

10.  Auditing and Compliance:

1. • Conduct internal audits to ensure compliance with quality management systems and regulatory requirements.
   • Prepare for and support external audits by regulatory bodies and customers.

Qualifications:

• 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.

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.