As a cardiovascular device business, CircuLite is dedicated to insuring that our Synergy® Circulatory Micro-Pump provides our potential patient population with a product which will improve the quality of their life. Quality and excellence are not only words to us at CircuLite, they are at the heart of how we conduct our business, craft our product and recruit and develop our team.
Position
Engineer/Senior Engineer, Quality Assurance
Location
Aachen, Germany
Status
Full Time
Job Summary
The successful incumbent is an integral participant in maintaining CircuLite’s Quality Management System through documentation of design and manufacturing efforts relating to the production of the Synergy Circulatory Micro-Pump.
The incumbent takes direction from the Sr. Manager, Quality Assurance (located at our Saddle Brook, NJ office) and has a dotted line responsibility to the Managing Director, CircuLite, GmbH (Aachen, Germany).
Some travel domestically and internationally is required.
Specific Duties
• Coordinate complaint investigations and insure follow-up to CAPA assignment or complaint closeout, as applicable.
• Coordinate corrective action decisions, implementation and effectiveness, including assignment of CAPA report numbers and review and approval of CAPA reports and verification of effectiveness.
• Maintain inspection sampling plans, including sample reduction were applicable.
• Maintain the Approved Supplier Listing and internal documentation for new supplier initiation and supplier evaluation/re-evaluation, including conducting supplier evaluations/re-evaluations as needed.
• Oversee and maintain Finished Goods Inventory System, including Device History Record closure and release.
• Oversee and maintain Returned Goods System, including product disassembly evaluations.
• Coordinate and maintain Clean room Monitoring System.
Qualifications
Bachelor of Science (or equivalent), preferably in life science/medicine and certification in a quality discipline (CQM or CQE preferred).
Must be able to read, write and verbally communicate in German and English.
Five-Seven (5-7) years prior quality assurance/quality engineering experience, preferably in sterile implantable medical devices.
In-depth knowledge of analytical statistics and strong knowledge of international regulatory requirements, with knowledge of FDA Quality System Regulations, ISO 13485 and ISO 14644 standards.
Relocation Not available for this position.
To Apply for This Position go to information@circulite.net.
Search Firms: Unsolicited resumes without a valid written search agreement in place for this position will be judged the sole property of CircuLite and no fee will be paid if the candidate is successful in being hired.
