The Quality Engineer in Medical Plastic Injection Molding is responsible for overseeing and ensuring the quality of products and processes within the medical device manufacturing environment. This role involves implementing quality assurance practices, ensuring compliance with regulatory standards, conducting audits, and driving continuous improvement initiatives.
Key Responsibilities:
- Quality Assurance:
- 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.
- Regulatory Compliance:
- Ensure that all products and processes comply with relevant medical device regulations and standards, such as ISO 9001, 13485, and applicable FDA requirements.
- Prepare and manage documentation for regulatory submissions and audits.
- Process Monitoring and Improvement:
- Monitor injection molding processes to ensure consistent product quality.
- Identify areas for process improvement and lead initiatives to enhance product quality and manufacturing efficiency.
- Data Collection and Analysis:
- Collect and analyze data on product quality and process performance.
- Prepare reports on quality metrics and trends to inform decision-making.
- Problem Solving and Root Cause Analysis:
- 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.
- Supplier Quality Management:
- Evaluate supplier quality performance and conduct supplier audits.
- Work with suppliers to resolve quality issues and ensure the supply of high-quality materials.
- Customer Interaction:
- Address customer complaints and quality concerns.
- Support customer audits and visits by providing necessary documentation and information.
- Continuous Improvement:
- Drive continuous improvement initiatives aimed at enhancing product quality, reducing waste, and improving efficiency.
- Participate in and lead cross-functional quality improvement teams.
- Training and Development:
- Mentor and train quality control personnel and junior quality engineers.
- Conduct quality-related training programs for manufacturing and other relevant staff.
- Auditing and Compliance:
- 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.
- Experience in Metrology, preferably with programming experience.
- 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 9001, 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.