New Products Project Manager jobs in Illinois

Function: Project Management

Summary

EdgeOne Medical is seeking a Quality Assurance Specialist to join our growing organization. This role includes maintenance and optimization of the QMS to Medical Device standards.

Please send your resume and a cover letter to careers@edgeonemedical.com and include Quality Assurance Specialist in the Title.

Essential Duties and Responsibilities

• Implementation and validation of an e-Quality Management System.
• Maintenance, performance monitoring and continual improvement of the QMS.
• Establish standards of performance within the QMS.
• Directly support QMS certifications as well as internal and external audits.
• Lead Quality activities for CAPA and Change Management.
• Support QMS process improvement projects as well as business improvement initiatives.
• Support development of SaMD QMS requirements.
• Support Clients with QMS consulting services for Medical Devices & Combination Devices.
• Reporting directly to the Senior Director of Quality in a small team with a large industry leading Client base.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• Bachelor or advanced degree in Engineering or Life Science.
• Expert knowledge and interpretation of ISO 13485:2016 and 21CFR820
• Strong knowledge of Regulation (EU) 2017/ 745, MDSAP, ISO 17025, GDP, GLP and GMP
• Organized, proactive, analytical thinking, with strong teamwork, communication and management skills.
• Preferable experience in Design Controls,
• Preferable experience problem solving & process improvement, Lean Six-Sigma training an advantage.
• Minimum of 5 years of experience demonstrating knowledge of a wide range of QMS activities across the Medical Device Product Life Cycle.

Equal Employment Opportunity

Discrimination in hiring, promotion and all other employment decisions on the basis of race, color, religion, gender, national origin, age, disability, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other basis protected by Federal, state or local laws is prohibited.