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, 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 audits of raw materials, in-process products, and finished goods to verify adherence to quality standards. Conduct Process Validations for new and revised products and processes ensuring long term capability. Schedule Inspection resources to provide data supporting project work for on-time completion.

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.

Process Monitoring and Improvement:

Monitor production 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 and routine surveys. Participate in review and approval of New Suppliers. Provide routine review and maintenance of the Company Approved Supplier List (ASL). Work with suppliers to resolve quality issues, including issuance and followup on Corrective Actions, to ensure the supply of high-quality materials.

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. 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.

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.

Additional Information:

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

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