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- Round Lake Illinois, IL
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Apex Systems • Round Lake Illinois, IL
Posted 7 days ago
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Department: Quality (Risk Management)
This role will be responsible for representing the global risk management process in leading Risk file generation for legacy products (disposable devices and/or drug products). The individual in the position will be required to facilitate the collaboration of information from medical, R&D, quality engineering and maintain compliance to the quality system in order to generate a risk management file. The incumbent will perform other duties assigned as required to support the larger risk management goals and initiatives.
1) Act independently with minimal supervision to conduct smaller approved projects. Expected to make suggestion on improvements based on recent technical knowledge.
2) Contribute to the planning and execution of components of the development process, which apply to product revision or enhancement or a defined piece of a larger project.
3) Ability to manage routine small projects without assistance.
4) Investigate and analyze customer complaint data and design documentation.
The individual must be proficient in working and generating documents in a GDP environment and a working knowledge of risk management (ISO 14971) or ability to quickly gain knowledge in this area.
1) Knowledge of the basic principles in various engineering disciplines.
2) Must have initial training in concepts of Six Sigma quality techniques.
3) Must know how to effectively run projects, coordinate contractors, and direct the activities of a technician
Education / Experience
1) Bachelor of Science in either Engineering or Science
2) 1 - 3 years recent, related experience in a regulated environment.
3) Experience with GDPs and GMPs
4) Experience with Design History File (DHF), strongly preferred.
5) Previous project coordination/management experience strongly preferred. Even candidates that have project engineering degrees and experience highly desirable.
6) Software: Excel (Pivot Tables, V-lookups, etc.)-required, PowerPoint, Outlook, Word, SharePoint
7) Nice to have Software: Trackwise 8, Minitab & DOORS
8) Previous compliant experience, nice to have
9) Soft skills: adaptable, resourceful, ability to follow up and knowledge of when to escalate.
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178