Quality Engineer (MED DEVICE)
The Quality Engineer in Medical Plastic Injection Molding is responsible for overseeing and ensuring the quality of existing and new products and processes within the medical device manufacturing environment. This role involves implementing quality assurance practices, measurement of product utilizing CMM, 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.
- Create and maintain Quality Assurance documentation including Control Plans, pFMEAs, Quality Alerts, and Inspection Plans.
- Conduct Process Validations for new and revised products and processes ensuring long term capability.
- Monitor production processes to ensure consistent product quality.
- Collect and analyze data on product quality and process performance.
- Quality Control:
- Conduct audits of raw materials, in-process products, and finished goods to verify adherence to quality standards.
- Measure parts using hand gages, CMM, Video Measurement System.
- Ability to interpret part prints. Utilize GD&T when applicable.
- Regulatory Compliance:
- 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.
- 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.
- Customer Interaction:
- Address customer complaints and quality concerns including processing of Return Material Authorization, RMA, and formal Corrective Actions.
- Support customer audits and visits by providing necessary documentation and information.
- Support and provide routine status updates to Customers regarding open actions including, but not limited to, Corrective Actions, Projects, and/or other Status Updates.
- Active participant in Drawing Reviews to ensure that Quality Requirements can be satisfied.
- Support Quality requirements for New Product Introduction working closely with Program Managers to support critical timelines for completion.
- Continuous Improvement:
- Drive continuous improvement initiatives aimed at enhancing product quality, reducing waste, and improving efficiency. Provide review of any changes for impact on QMS.
- Identify areas for process improvement and lead initiatives to enhance product quality and manufacturing 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.
- 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.
- Experience working with CMMs to measure parts. Some programming experience preferred but will train if needed.
- 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.
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