Job description
Medartis develops, manufactures and distributes titanium screws and plates, surgical instruments and system solutions for fracture fixation. Our motto is “Precision in Fixation”. We place the highest priority on maintaining stringent quality standards, continuous further development and innovation as well as comprehensive service provision for physicians, staff and patients.
Your responsibilities
- GENERAL RESPONSIBILITIES:
- Manage CAPA system along with assigned CAPA responsibilities.
- Organize and analyze quality data and metrics including coordination of Management Review meeting.
- Prepare and update Quality documents such as SOPs, Work Instructions and Forms.
- Review and approve records and documents to ensure conformance with regulations and Medartis procedures.
- Drive continuous improvement of the Quality Management System, including non-conformance evaluations, root cause analysis and implementation of corrective actions.
- Conduct internal audits to ensure compliance of the Quality Management System.
- Participate in cross-functional quality improvement projects as required.
- Follow FDA Quality Systems Regulation, ISO Standards and Standard Operating Procedures as established by Medartis policies, practices and procedures.
- Maintain effective working relations, communications and feedback with all other departments.
- Ensure that all record keeping, and documentation is completed in a timely manner according to established policies, practices and procedures.
- Perform other duties as required.
Your qualifications
- SKILL AND EDUCATION REQUIREMENTS:
- Bachelor of Science in Engineering or related field, or equivalent combination of experience and training.
- Previous experience in a regulated industry is preferred.
- Medical Device Audit experience preferred.
- Proficient in the use of Microsoft Word, PowerPoint and Excel.
- Knowledge of basic engineering principals.
This is an integral, responsible and diversified role with a focus on quality and service provision in a rapidly growing, international company. We look forward to receiving your complete application.
Medartis Inc. is an EO employer – M/F/Veteran/Disability. "We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law."
We look forward to receiving your complete online application.
We look forward to receiving your complete online application.
Medartis
Human Resources
T +1 610 961 6101
Human Resources
T +1 610 961 6101
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