Smiths Medical is a leading supplier of high-quality medical devices and products for global markets. We design and manufacture specialist medical devices in three key areas: Safety Devices, Vital Care and Medication Delivery.

Smiths Medical's customers include hospitals, alternate care such as home care, and other healthcare providers worldwide. Smiths Medical, which employs over 7,500 people on six continents, is part of the global technology business Smiths Group, a world leader in the practical application of advanced technologies. We have exciting career opportunities available for forward-thinking, motivated individuals who strive to succeed. Join us as we continue making medical product history!

Position Description
The Senior Quality Systems Engineer shall ensure that all Quality System procedures are established under one system that implements the requirements of the FDA, ISO 9001, ISO 13485, Medical Device Directive (MDD), and other national and international regulatory requirements, as may be established from time-to-time. Primary responsibility is for the Smiths Medical MD, Inc., St. Paul facility. Ensures the CAPA systems are operating effectively and close out of corrective actions meets expected deadlines. Coordinate product recalls. Submits regular status report to management to clearly demonstrate the effectiveness of the quality and CAPA systems.

Requirements

Implement & Maintain Quality System Processes and Procedures.

• Review, revise, and consolidate Quality System procedures to bring about better efficiency and compliance. Identify inconsistencies in procedures and consolidate/rectify the problem with the establishment of multi-disciplined teams, where appropriate. Emphasis to be placed on use of "Process Maps".
• Streamline the Quality System procedures to ensure that they are clear and easily understood by the appropriate personnel and reflect the actual process.
• Develop a 'roadmap' of the procedures that they can easily be connected and located.
• Maintain quality system manuals.
• Develop and provide QMS training to new employees and refresher training for existing employees.
• Submits regular management reports to demonstrate the effectiveness of the QMS.
• Assist the Quality System Manager with external audits of the QMS and response to any audit findings e.g. FDA inspections, European Notified Body audits, customer audits etc.

Implement and Maintain an Effective CAPA Process.

• Review, revise, and consolidate CAPA system procedures to bring about better efficiency, reduce in-process assembly problems, product field complaints and regulatory compliance.
• Follow-up on corrective actions to ensure they implemented on time and are effective.
• Submits regular management reports to demonstrate the effectiveness of the CAPA system.

Implement and Coordinate internal audit process of the quality system.

• Maintaining the audit schedule and database.
• Follow-up on internal audit reports and corrective actions.
• Submit status reports to management.
• Generate and communicate metrics to the organization.

Coordinate Product Recalls

• Generate Product Recall Authorization documents.
• Coordinate the recall activities.
• Communicated with regulatory authorities such as the FDA and submit monthly status reports.
• Effectively track the return product and implement disposition.
• Close the recall.

Perform other responsibilities as directed by the Quality System Manager

Minimum Education and Experience

• Bachelor's degree from an accredited college or university. Five to seven years direct experience in a FDA regulated company or similar environment with Quality Systems Experience in GMP and ISO quality system standards. Certification as ASQC auditor or ISO 9000, ISO 13485 assessor very desirable.

Minimum Knowledge Abilities and Skills

• Trained in Quality System Regulation and documentation techniques. Trained in Quality Management Systems, ISO 9001, ISO 13485, and 21 CFR 820, Internal Auditor Lead Assessor training.
• Good understanding of CAPA systems and implementation.
• Planning skills to develop quality assurance plans, policies/procedures, and systems to meet standards and business requirements.
• Demonstrated excellent verbal communications skills and technical writing ability. Able to plan and conduct effective meetings and group presentations. Able to provide technical presentations to internal and external audiences.
• Good knowledge of the processes and regulatory requirement covering product recalls.
• Ability to coordinate and lead project team activities in an effective and proficient manner. Team members typically include diverse inter-department staff including Regulatory, Marketing, Purchasing, Operations and R&D. Leading these cross functional teams requires a significant level of organization and motivation skills.
• Understanding of medical device industry and products.
• Skill in developing training programs to meet individual and group needs.
• Ability to train, instruct and advise in both formal and informal environments.
• Excellent interpersonal skills to interface with all levels of company structure as well as representatives of outside agencies or companies.
• Ability to assimilate regulatory publications and convey their principles and practical effects to the organization.
• Good leadership skills.
• Good decisions making and problem solving skills
• Ability to handle and work under stressful situations.

Smiths is a global technology company listed on the London Stock Exchange. For further information, visit www.smiths-medical.com

Smiths Medical offers a competitive salary, excellent benefits, and exciting opportunities for career advancement.

For additional detailed information regarding this opportunity and to apply online, please visit:
http://smithsmedicalcareers.123jobfocus.com/jobmanager/index.php?p=detail&job_id=2473&keyword=&job_catid=&loc_id=&experience_id=®ister =

Smiths Medical is an equal opportunity employer.