Compliance Engineer IV
KARL STORZ Industrial-America, Inc.
KARL STORZ Endovision (KSE) develops, manufactures and services fiberoptic and digital video endoscopes. KSE services all flexible endoscopes distributed in North America, as well as, many globally distributed endoscopes. The facility also manufactures and services a variety of electromechanical devices -light sources, insufflators and other electronic accessories that provides high quality medical care. To become part of this dynamic team, we invite you to learn more about our opportunities.
The purpose of this position is responsible to support the Flexible Endoscope Development Group by ensuring new design projects are executed and documented according to national, international, and company standards.
All employees are expected to be knowledgeable about and follow the Company’s Equal Employment and Affirmative Action Policies, including policies on the rights of individuals with disabilities and harassment.
Participate in product development teams to create and manage design history files through the design control process.
Ensure compliance with FDA/QSR and ISO design control regulations.
Responsible for participating in the Design Controls portion of all regulatory agency audits which involve Flexible Endoscope Development.
Perform internal audits of Design History Files and FED procedures and documentation to ensure compliance.
Investigate and respond to corrective actions in a timely manner.
Serve as a point of contact for Karl Storz Regulatory Departments.
Responsible to understand the application of relevant standards to the activities of Flexible Endoscope Development, to stay current on new revisions, and to ensure compliance.
Performance of gap analysis for revised applicable standards.
Identify and review new standards to determine applicability to Flexible Endoscope Development instruments.
Perform / assist / document Verification testing as necessary.
- Bachelor’s degree required – Mechanical, Electrical or Software Engineering preferred
- 5 or more years experience in a Medical Device design / manufacturing environment working under FDA and/or ISO regulations. Experience in new product development preferred.
- Experience with the application of FDA and/or ISO Quality System Requirements required. Specific experience with Design Controls Requirements preferred.
- Experience with the application of IEC and ISO standards for medical devices and/or MIL-STD for Industrial applications preferred.
- Excellent written and oral communication skills.
- Ability to read blueprints / schematics and to draft technical documentation required.
- Experience with MS Office required. MS Project and SAP a plus.
- Organizational and time management skills essential.
- Experience with internal auditing a plus.
- Knowledge of SolidWorks and proficiency in German desirable.