Manager/Sr. Manager, Manufacturing Quality
- Germantown, MD, USA
Come be a part of the company that is transforming the way diabetes care is being delivered to patients across the globe!
Senseonics, maker of the first and only 90-day continuous glucose monitoring (CGM) implantable sensor (Eversense), is looking for people to create excitement and drive adoption for this new, life-changing technology. Eversense, our Continuous Glucose Monitoring System, is designed to be the first fully implantable continuous glucose monitoring system that is highly accurate and stable throughout its long sensor life and will enable people with diabetes to live their lives with ease!
The candidate must be capable of managing the quality system, interface with contract manufacturers and critical suppliers, and participate in internal and external audits.
- Ensure compliance with FDA quality system regulations, ISO 13485 requirements and Medical Device Regulation (MDR)
- Ensure all aspects of the quality system are maintained and monitored for continuous improvement
- Ensure all aspects of Quality at Contract Manufacturers including change management and product release for commercial distribution
- Ensure ongoing management of company-wide ISO/ GMP quality systems including but not limited to CAPA, non-conformances, audits, customer complaints & deviations, and Risk Management activities.,
- Responsible for assigning NCRs, participating on the MRB, and tracking NCRs to completeness.
- Participate as member of Internal and/or External Audit team
- Assist in the development and submission of Design Dossier and PMA applications
- Interact with Operations, Engineering, and Clinical groups and provide the necessary support to achieve high quality and reliability product
- Bachelor’s degree with 7+ years of work experience in quality and/or engineering
- Minimum 7 (+) years in a Quality Department in the regulated industry. Experience in Manufacturing Quality in a Medical Device company preferred.
- Experience must include, document control, batch release, incoming inspection, validation, design control activities and management/maintenance of the Quality Management System
- Must have knowledge of root cause analysis, corrective/preventive actions and process improvement
- PPAP and MSA process knowledge preferred
- Demonstrated analytical and database decision-making skills, statistical sampling and analysis and proficiency with Minitab, JUMP or other similar statistical software tools.
- Must be skilled in use of Microsoft Office Word, Excel, PowerPoint
- Experience in risk assessment tools, such as FMEA, FTA
- Must demonstrate highly developed communication skills including well developed writing skills and verbal and interpersonal skills
- Ability to organize tasks, work independently and adapt to changing priorities
- Ability to define problems, collect data, establish facts and draw valid conclusions.
- Ability to function in a minimally supervised environment with exceptional attention to detail required
- Extended work hours may be necessary in order to meet business demand
Senseonics is an Equal Opportunity Employer and does not discriminate based on race, religion, gender, national origin, color, age, military service eligibility or veteran status, disability, sexual orientation, marital status or any other protected class. We offer competitive salaries and benefits.