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!

QUALITY SYSTEM ENGINEER
St. Paul, MN

Supported by two to five years direct experience in a FDA-regulated company or similar environment with Quality Systems, and experience in GMP and ISO quality system standards, the successful candidate will perform quality systems engineering work requiring full competency in all conventional aspects of quality systems relating to Smiths Medical ASD, Inc. The incumbent will develop process improvements and maintain quality systems that conform to medical device market requirements and lead efforts to meet the quality objectives and goals established through business planning. The 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. Additional duties include ensuring the CAPA systems are operating effectively and close-out of corrective actions meets expected deadlines, coordinating product recalls and submitting regular status reports to management to clearly demonstrate the effectiveness of the Quality and CAPA systems. The selected candidate will also coordinate all Material Review Board activities, such as record maintenance, data entry, report generation, meeting facilitation, and Discrepancy Report (DR) review, process DA/DRs and track status of corrective action to ensure DR is complete and all corrective actions are closed, provide assistance and training to personnel who use the DA/DR database, fill out the DR form and process the DR and track status and corrective action for internal auditing to ensure internal audits are complete and all corrective actions are closed.


Qualifications include:

Bachelor\'s degree from an accredited college or university; MBA preferred.
Training in Quality System Regulation and documentation techniques, Quality Management Systems, ISO 9001, ISO 13485, 21 CFR 820, and Internal Auditor Lead Assessor.
Good understanding of CAPA systems and implementation and good knowledge of the processes and regulatory requirement covering product recalls.
Understanding of medical device industry and products.
Knowledge and skill in engineering documentation procedures, development methods and project management, with the ability to rapidly master Smiths Medical ASD, Inc. internal procedures and methods, such as Documentation System, CAPA, and others.
Knowledge of Statistical Process Control (SPC) and quality tools including sampling, tables, and CPK.
Ability to design and perform required tests using appropriate tools.
Knowledge of computer hardware, personal computers, and single purpose embedded micro systems.
ASQ certifications as biomedical auditor and quality engineer or ISO 9000, ISO 13485 assessor very desirable.
American Society for Quality Certification in Quality Engineering is preferred.

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.

Interested candidates, apply online at the direct link below:

http://smithsmedicalcareers.123jobfocus.com/jobmanager/index.php?p=detail&job_id=2428&keyword=&job_catid=&loc_id=&experience_id=®ister=

For more information about this and other great opportunities, visit us at: www.smiths-medical.com/careers


Smiths Medical is an equal opportunity employer and does not discriminate on the basis of race, colour, sex, national origin, religion, age, physical or mental disability, veteran status or any other basis protected by applicable federal, state or local law in the terms or conditions of employment, programs or activities. Individuals with questions regarding this policy are encouraged to contact Human Resources.

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