Director, Quality Assurance

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 highly experienced Director, Quality Assurance to establish, lead, and continuously improve the CRC EP Quality Management System while providing strategic Quality Engineering leadership for breakthrough pulsed-field cardiac ablation technologies. The ideal candidate will bring at least 10 years of progressive experience in Quality Assurance, Quality Engineering, or Systems Engineering within the cardiac medical device industry, with deep expertise in

ISO 13485

, EU MDR 2017/745, ISO 14971, FDA regulations, design controls, risk management, validation, CAPA, NCRs, and supplier quality. This role will serve as Management Representative and one of the Persons Responsible for Regulatory Compliance, partnering closely with Regulatory Affairs, Engineering, Clinical, Operations, suppliers, contract development organizations, Notified Bodies, FDA, and state regulatory agencies to ensure quality system compliance, product conformity, audit readiness, and successful regulatory approvals. Key Responsibilities Quality Management System Leadership Lead the development, implementation, maintenance, and continuous improvement of the Company Quality Management System. Develop and maintain the Quality Manual, critical SOPs, and quality system processes required to support regulatory readiness and commercial launch. Serve as Management Representative with responsibility for QMS documentation, effectiveness reporting, improvement planning, and promotion of regulatory and quality system awareness across the organization. Lead quality system activities supporting ISO 13485 certification, EU MDR compliance, FDA readiness, and applicable state regulatory expectations. Regulatory Compliance & Audit Readiness Serve as one of the Persons Responsible for Regulatory Compliance, supporting product conformity prior to commercialization and confirming post-market surveillance obligations are met. Manage quality-related interactions with Notified Bodies, FDA, California Food and Drug Branch, critical suppliers, and contract development organizations. Lead and support internal, supplier, notified body, regulatory, and customer audits, including audit preparation, documentation, responses, and follow-up actions. Monitor evolving regulatory requirements, standards, guidance documents, and industry best practices applicable to Class III cardiac ablation technologies. Quality Engineering & Product Development Provide Quality Engineering leadership throughout product and process development to ensure compliance, manufacturability, serviceability, testability, reliability, and conformance to product and quality system requirements. Support verification and validation activities for sterilization, biocompatibility, package integrity, shelf life, reliability, software validation, and electrical safety. Oversee product risk management files and ensure risk documentation remains aligned with design controls, clinical use, complaints, nonconformances, and post-market information. Manage Design History Files to ensure documentation is complete, accurate, inspection-ready, and aligned with cross-functional development activities. Supplier Quality, CAPA & Continuous Improvement Manage critical suppliers on quality-related activities, including supplier qualification, audits, quality agreements, documentation management, and corrective actions. Lead failure investigations, nonconformance evaluations, root-cause analysis, CAPA activities, retrospective reviews, remediation plans, and effectiveness checks. Identify and implement good quality engineering practices, including statistical methods, root-cause analysis tools, and continuous improvement methods. Your Profile Education Requirements Bachelor’s degree in health, life sciences, engineering, biomedical engineering, or a related field. Advanced degree preferred. Experience Requirements Minimum 10+ years of progressive experience in Quality Assurance, Quality Engineering, or Systems Engineering within the cardiac medical device industry, preferably cardiac ablation. Demonstrated lead-role experience implementing a QMS and relevant SOPs and successfully supporting audits leading to ISO 13485 certification. Experience with Design Control, Risk Management, process qualification, validation, IQ/OQ/PQ activities, CAPA, NCRs, GMP, and supplier quality. Experience interacting with contract manufacturers, contract development organizations, Notified Bodies, FDA, and other regulatory authorities. Technical Expertise Deep working knowledge of: ISO 13485

EU MDR 2017/745

FDA Quality System Regulation and applicable FDA guidance Design Controls and Design History Files CAPA, NCRs, complaints, failure investigations, and root-cause analysis Verification and validation, including IQ/OQ/PQ Biocompatibility, sterilization, packaging, shelf life, reliability, software validation, and electrical safety standards Supplier qualification, supplier audits, and supplier quality management PMA, 510(k), CE Mark, and Class III device regulatory processes Additional Preferred Knowledge, Skills and Abilities Experience with cardiovascular, electrophysiology, cardiac ablation, or other Class III medical devices. Experience working directly with European Notified Bodies, FDA, state regulatory agencies, and contract manufacturers. Strong knowledge of GMP, international standards, quality system audits, and supplier controls. Demonstrated experience supporting clinical trial monitoring, audits, and/or inspections is preferred. Expert knowledge of medical device quality system requirements and regulatory expectations. Strategic leadership with the ability to influence cross-functional teams and senior stakeholders. Strong analytical, problem-solving, root-cause analysis, and decision-making capabilities. Exceptional written and verbal communication skills, including the ability to present quality and compliance topics to executive leadership and external regulatory audiences. High attention to detail with the ability to manage multiple complex priorities in a fast-paced development environment. Physical and Travel Requirements The physical demands described within this job posting are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer for extended periods of time and communicate with co-workers, suppliers, auditors, and external regulatory stakeholders. Must be able to work a minimum of 40 hours per week. Must be able to work onsite at the Tustin, CA facility as business needs require. Must be able to travel domestically and internationally up to 30% of the time to support audits, supplier activities, regulatory interactions, and business needs. Work Location This role is based at our Tustin, CA office. This position is performed primarily in a professional office environment and requires regular use of a computer, standard office equipment, quality system documentation, engineering and regulatory records, and virtual communication tools. Work involves extended periods of sitting, reading, writing, typing, document review, and participation in meetings, with occasional work in laboratory, manufacturing, supplier, audit, or controlled environments to support quality engineering, validation, supplier management, and regulatory activities. The employee is expected to maintain confidentiality and comply with applicable company policies, quality system requirements, and regulatory standards. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position. What We Offer Competitive base salary, with a negotiable performance bonus. Opportunity to shape quality strategy for breakthrough cardiac technologies. A collaborative, mission-driven environment where your expertise has immediate impact. BIOTRONIK EP CRC is dedicated to fair and equitable compensation practices. The base salary range for this position is $150,000 - $220,000 per year, based on experience and qualifications. In addition to base salary, BIOTRONIK EP CRC offers a bonus program and comprehensive benefits package, which includes health insurance, retirement plans, paid time off, and other perks. Compensation may vary depending on geographic location, skills, experience, and other factors. #J-18808-Ljbffr BIOTRONIK