Quality Engineer (Medical Device or Pharmaceutical Manufacturing)

Immediate need for a talented

• Abide by, enforce, and participate in the implementation and ongoing oversight of all company safety standards and regulations.
• Implement and maintain the business group’s Quality Program, including a corrective action and preventive action (CAPA) program to ensure that potential problems and root causes for deviations and non-conformances are identified, possible consequences assessed, and actions to prevent recurrence considered.
• Respond to customer complaints, correspondence, requests, and requirements; liaise with suppliers of raw materials and resolve production problems.
• Ensure the implementation of Quality policy and procedures for the business group. Develop quality policies and procedures for quality control of laboratory and production efforts.
• Lead root cause investigations into Quality issues, with corrective and preventative actions, including complaints concerning a company product or materials used in the manufacture of the product. Recall product, when warranted.
• Prepare, review, and/or approve the Declaration of Conformity for all medical devices.
• Ensure proper review, approval, and change management to any procedure, specification, manufacturing procedure or process, equipment, instruments, test method, and validated system with potential impact on product and or process quality.
• Transfer new technologies across a range of product categories.
• Ensure appropriate GMP and QA systems training of department and QA personnel, suppliers, and relevant customers, including but not limited to GMP and related training activities.
• Advice on equipment modification to enable process changes for new product development.
• Develop and write cost estimates, document development work and implement profit improvement programs.
• Coordinate the integration of new products with other commercial areas, including brand development, sales strategy, quality assurance, legal, marketing, and manufacturing.
• Engage in continuous improvement on an ongoing basis to proactively mitigate current and future risks and maintain effective operations to support business needs.
• Support manufacturing facilities within the business group with their Quality Improvement process by giving constant feedback based on customer and consumer feedback.
• Provide input into planning, development, and implementation of changes to policies, procedures, forms, etc.;
• Facilitate changes in procedures, forms and practices, workflows, personnel assignments, and equipment.
• Develop, plan, and implement special projects as assigned.
• Maintain current knowledge in the field by active participation in related professional organizations, learning opportunities and regularly reviewing current technical literature.

• Bachelor's degree in a scientific discipline, pharmacy, or engineering from a four-year college or university, preferably Chemical Engineering or Chemistry.
• Over 4 years (4) years of progressive experience and demonstrated successes in Medical device (or) Pharmaceutical Manufacturing industries or equivalent combination of education and experience.
• Quality Operations/Quality Systems knowledge and experience with FDA QSR’s, CAPA, GOTS, Harmonized Standards & regulations.
• Experience interacting directly with regulatory agencies and certifying bodies required.