Job Title: Quality Engineer

Job Description

We are seeking a skilled Quality Engineer with proven leadership capabilities to oversee and enhance our quality assurance systems. The ideal candidate will be responsible for ensuring compliance with medical device regulations, improving manufacturing processes, and driving continuous quality improvements within our dynamic and growing company.

Responsibilities

• 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.
• Ensure all products and processes comply with relevant medical device regulations and standards, including ISO and FDA 21 CFR Part 11 and Part 820 requirements.
• Prepare and manage documentation in support of regulatory submissions, audits, and inspections.
• 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.
• 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 personnel.
• 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.
• 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.
• Serve as the primary point of contact for customer quality concerns and complaints.
• Support customer audits and visits by providing necessary documentation and information.
• Drive continuous improvement initiatives aimed at enhancing product quality, reducing costs, and improving efficiency.
• Lead and participate in cross-functional quality improvement teams.
• Develop and conduct training programs for quality assurance personnel and promote a culture of quality awareness and continuous improvement within the organization.
• Conduct internal audits to ensure compliance with quality management systems and regulatory requirements.
• Prepare for and support external audits by regulatory bodies and customers.

Essential Skills

• Minimum of 7-10 years of experience in a quality role within the medical device manufacturing industry.
• Extensive experience in plastic injection molding.
• Previous management experience required.
• 5+ years experience with FDA 21 CFR Part 11 and Part 820.
• 5+ years experience with ISO 9001.
• Strong leadership and team management skills.
• Excellent analytical and problem-solving skills.
• Proficiency in statistical analysis and quality management software.

Additional Skills & Qualifications

• Bachelor’s degree in engineering, preferably in Mechanical, Industrial, or Plastics Engineering. A master’s degree is a plus.
• Certifications such as Certified Quality Manager (CQM), Certified Quality Engineer (CQE), and/or Certified Quality Auditor (CQA) from ASQ are highly desirable.
• In-depth understanding of quality assurance principles and methodologies.
• Extensive knowledge of injection molding processes and equipment.
• Familiarity with medical device regulations and standards.
• Practical experience and knowledge of metrology and GD&T techniques.
• Effective communication and interpersonal skills.

Work Environment

This role is set in a fast-paced, deadline-driven manufacturing floor and office environment, requiring strong attention to detail and adaptability to shifting priorities.