Quality Manager

The Quality Manager in Medical Plastics Injection Molding is responsible for overseeing the quality assurance and quality control processes to ensure that all products meet the highest standards of quality and regulatory compliance. This role involves managing a team of quality engineers and technicians, leading continuous improvement initiatives, and ensuring compliance with relevant medical device regulations and standards.

Key Responsibilities:

1. Quality Assurance Leadership:

• Develop, implement, and maintain quality assurance policies, procedures, and systems to ensure product quality and compliance.
• Lead and mentor the quality assurance team, including quality engineers and quality control technicians.

1. Regulatory Compliance:

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

1. Process Monitoring and Improvement:

• Oversee the monitoring of injection molding processes to ensure consistent product quality.
• Identify and implement process improvements to enhance product quality, reduce waste, and improve manufacturing efficiency.

1. Data Collection and Analysis:

• Analyze data on product quality and process performance to identify trends and areas for improvement.
• Prepare and present reports on quality metrics and performance to senior management.

1. Problem Solving and Root Cause Analysis:

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

1. Supplier Quality Management:

• Manage supplier quality performance, including conducting supplier audits and assessments.
• Work with suppliers to resolve quality issues and ensure the supply of high-quality materials.

1. Customer Interaction:

• Serve as the primary point of contact for customer quality concerns and complaints.
• Support customer audits and visits by providing necessary documentation and information.

1. Continuous Improvement:

• Drive continuous improvement initiatives aimed at enhancing product quality, reducing costs, and improving efficiency.
• Lead and participate in cross-functional quality improvement teams.

1. Training and Development:

• Develop and conduct training programs for quality assurance personnel and other relevant staff.
• Promote a culture of quality awareness and continuous improvement within the organization.

1. 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. A master's degree is a plus.
• Experience: Minimum of 7-10 years of experience in a quality role within the medical device manufacturing industry, with significant experience in plastic injection molding. Previous management experience is required.
• 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 leadership and team management skills.
  • Excellent analytical and problem-solving skills.
  • Effective communication and interpersonal skills.
  • Proficiency in statistical analysis and quality management software.
• Certifications: Certification such as Certified Quality Manager (CQM) or 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.

Additional Information:

• May require occasional travel to supplier or customer sites.
• Must be able to work flexible hours, including weekends or evenings, as needed.