Quality Control Inspector

BIOTRONIK is one of the leading manufacturers of cardio and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees.

California Research Center Electrophysiology, Inc (CRC EP, Inc.), a Biotronik business unit located in Tustin, CA, develops pulsed-field cardiac ablation (PFA) technologies. The team has recently completed the First-in-Human clinical trial which validated the company’s PFA technology for treatment of atrial fibrillation. The team is embarking on preparing the technology for regulatory approvals followed by commercial release in respective territories. We are continually looking for talented engineers, scientists, and professionals to share in our mission.

We are seeking a QC Inspector role is a critical role ensuring the planning and execution within CRC EP catheter manufacturing group. This role is integral with manufacturing engineering and quality control. This is accomplished by performing receiving inspections including First Article (FA) inspection, in-process and final inspection, writing inspection protocols and reports, working closely with manufacturing engineering to develop material specs and inspection criteria, working closely with Quality to ensure compliance with CRC EP QMS.

• Perform First Article Inspection (FAI) of parts according to CRC EP procedures and conduct visual, mechanical, electrical, and dimensional inspections of incoming materials.
• Support the receiving process for incoming parts and verify label accuracy against approved artwork, component specifications, and documentation.
• Work with CRC EP procurement and/or engineering to collect incoming material documents when needed.
• Conduct visual, mechanical, electrical, and dimensional inspections of incoming material, in-process product, labeling, and final assemblies.
• Conduct electrical testing (continuity, insulation resistance, Hi-Pot) and mechanical testing (Peel Testing, Tensile Testing).
• Inspects in-process and final inspection of production materials by confirming specifications, conducting visual and measurement tests, communicating required adjustments to Manufacturing Manager or Engineering.
• Approves finished products by confirming specifications, conducting visual and measurement tests, returning products for re-work, and confirming re-work.
• Follows verbal and/or written instructions such as lot history record, work instruction, and process specifications at the direction of Manufacturing Manager or Engineering in completing a variety of inspection tasks.
• Performs product release according to lot release requirements.
• Records inspections and reviews DHRs for completeness, correctness, and compliance with GDP practices.
• Compile, maintain, summarize, and analyze inspection and quality data using Microsoft Excel and other electronic systems to support investigations, supplier performance monitoring, and continuous improvement activities.
• Work quickly and efficiently to achieve targeted goals as set by the production schedule
• Keeps measurement equipment operating by following operating instructions and calibration requirements and calling for repairs.
• Support internal and external audits, as necessary.
• Initiates Nonconforming Material Reports (NCMR) on nonconforming / unacceptable materials.
• Participate in CAPA processes.
• Maintains safe and healthy work environment by following standards and procedures and complying with legal regulations.
• Work collaboratively…