Medical Quality & Manufacturing Engineer (Genesis Medical Plastics)

About Us:

Genesis Medical Plastics was established to meet the specialized needs of the medical industry through dedicated polymer conversion capabilities. As part of Drake Plastics, we partner closely with customers to deliver high-quality, precision components from advanced materials, supported by a team focused on expertise, responsiveness, and continuous improvement.

Position Summary:

The Medical Quality Engineer is responsible for ensuring that medical device products meet the highest standards of quality, safety, and compliance throughout the product lifecycle. This role involves working closely with cross-functional teams, conducting product testing, analyzing data, and managing quality systems to comply with regulatory requirements. The Medical Quality Engineer plays a key role in continuous improvement efforts, risk management, and maintaining compliance with industry standards such as ISO 13485 and FDA regulations.

Key Responsibilities:

Maintain quality management systems (QMS) in compliance with

ISO 13485, FDA

regulations (21 CFR Part 820), and other applicable standards. Ensure the company's QMS effectively monitors and controls the quality of products and processes. Conduct internal and external audits to ensure compliance with regulatory and quality standards. Lead process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to ensure that manufacturing processes produce consistent, high-quality results. Work with the design and development teams to validate new products, ensuring that they meet safety and performance requirements. Lead Continuous Improvement (CI) initiatives, focusing on enhancing product quality and process efficiency. Manage the Corrective and Preventive Action (CAPA) system, including root cause analysis, action plans, and effectiveness monitoring. Develop and execute test protocols for product verification and validation. Ensure all products meet safety, performance, and regulatory requirements before release. Analyze test results, generate reports, and make recommendations for product improvements or corrective actions. Provide training to staff on quality systems, regulatory requirements, and good manufacturing practices (GMP). Ensure proper documentation of quality control activities, including testing, validations, and corrective actions. Maintain and update quality records following regulatory and company standards. Required Skills / Experience /

Education:

Bachelor's degree in engineering (Mechanical, Biomedical, Chemical, or related field). Master's degree is a plus. 3-5 years of experience in quality engineering, preferably in the medical device or healthcare industry. Familiarity with medical device regulations, including

ISO 13485, ISO

14971, and

FDA 21 CFR

Part 820. Hands-on experience with validation, risk management, and process improvement. Knowledge of quality engineering tools and methodologies, such as Six Sigma, Lean, FMEA, SPC, and CAPA. Excellent problem-solving skills and attention to detail. Strong communication and ability to work effectively with cross-functional teams. Work Environment /

Schedule:

Primary office environment with daily interface with operations and workshop staff. The standard work schedule is Monday - Friday, 8:30 am - 5:30 pm. Drake Plastics is a drug-free workplace. All applicants who receive conditional offers of employment will be subjected to pre-employment drug testing. dtApGst0CC