Sr. Quality Systems Engineer is responsible for developing, facilitating, maintaining and improving the Kalila / Terumo Medical Corporation (TMC) Quality System in accordance with applicable quality systems and regulatory requirements. This includes compliance to the FDA’s Quality System Regulation / Current Good Manufacturing Practices (21 CFR; Part 820), ISO-13485, Medical Device Directive and ISO 14971. Sr. Quality Systems Engineer will drive Quality System improvements companywide ensuring policies, procedures, and standards are current, compliant and addressing the needs of the business.
Sr. Quality Systems Engineer is responsible for developing and sustaining internal processes key to optimal performance of the Quality Management System (QMS) across Kalila / TMC sites. In addition, will collect and manage data and information, including audit findings, customer complaints, and customer surveys, necessary to assess the performance of the QMS. This scope includes analyzing key metrics for trends indicating the effectiveness of the QMS, making recommendations regarding system improvements and facilitating the training required to implement the improvements. The Sr. Quality Systems Engineer will monitor, analyze, and report QMS metrics to Senior Management, Management Representative, and key clients.
Sr. Quality Systems Engineer will support Management Reviews, Quality Systems Scorecards and Quality Performance Index (QPI). In addition, will support and participate in cross-functional projects when assigned, facilitate technical innovations to support business goals and assist with other Quality System activities as requested by management.
1. Responsible for facilitating efforts to plan, implement and maintain a plan of action to revise the existing Kalila / TMC Quality System in accordance with compliance requirements and the strategic needs of the business.
2. Responsible for coordinating the required training for all users on the major quality systems revisions and improvements.
3. Facilitate the incorporation of quality systems/regulatory requirements in accordance with FDA QSR (21 CFR: Part 820), ISO13485:2003/2016, European MDD / MDR, and all other applicable regulations.
4. Facilitate the incorporation of a process risk management procedure that defines the incorporation of a risk based strategy for process changes, development, validation and continuous improvement.
5. Analyze, develop and maintain key metrics for trends indicating the effectiveness and suitability of the QMS and identify areas for improvement.
6. Promote and audit corrective actions and continuous improvement efforts for quality management systems.
7. Make recommendations regarding system improvements and training required to implement the improvements.
8. Emphasize the awareness of quality system requirements, processes and deliverables throughout the organization.
9. Provide active support for internal, third party and customer audits. This requirement includes the post audit requirements for reviewing, dispositioning, mitigating and incorporating any observations, nonconformances, opportunities for improvement and potential gaps/preventive actions.
10. Develop, administer and continuously improve the training required to support the effectiveness and suitability of the quality system. This requirement includes the development, implementation and maintenance of cGMP Compliance, Good Documentation Practices, and compliance Process Development.
11. Provide practical, useful and effective quality systems reports for senior management, management reviews, business strategic initiatives and specific requests.
12. Support the development of a proactive and preventive quality systems culture throughout the business.
13. Complete other responsibilities as assigned.
Knowledge, Skills and Abilities (KSAs)
• Strong computer knowledge (MS Office), technical writing skills and proofreading ability
• Ability to establish and maintain a structured quality system development process (such as the Define, Develop, Implement, Evaluate and Improve process)
• Ability to clearly communicate (both verbal and written), with all levels of the organization
• Must have strong proofreading skills and organizational skills, as well as exemplary attention to detail
• Must have demonstrated initiative and ability to work independently while handling multiple tasks
• Good theoretical knowledge of ISO standards (EN 13485) and regulatory requirements (21 CFR 820 and related regulatory regulations).
• Must have a Bachelor’s degree in engineering or scientific discipline with a minimum of nine (9) years of in medical QA/RA systems environment or equivalent combination of education and experience.
• Must have two (2) to three (3) years of experience supporting a medical device/pharmaceutical environment and more specifically, developing quality systems for a regulated manufacturing operation for Class II or III medical devices.
• Previous experience in development and implementation of QA/RA systems in compliance with FDA Quality System Regulation, European MDD, and other applicable international regulations preferred.
• Must have experience in writing SOPs and other documents.
• Knowledge of and demonstrated ability to interpret the FDA Quality System Regulation (21 CFR-Part 820), ISO 13485, MDD, ISO 14971 and other medical device regulations, both domestic and international.
• Must have a demonstrated ability to successfully interact with all levels of managements, co-workers, and regulators.
• Must possess strong written, verbal and interpersonal communication skills.
• Ability to speak foreign languages is a plus.