Now Hiring - Lucent Surgical Support Systems, Inc. - Quality Assurance and Regulatory Manager - Medical Devices in Southfield, MI

Full description of the position

LUCENT Surgical Solutions ([please apply online] a medical device sales and service company based in Southfield, MI, is in the process of establishing a new facility and is seeking a Quality Assurance/Regulatory Affairs (QA/RA) Manager to join our expanding team. In this role, you will be responsible for overseeing the development, implementation, and management of quality systems and regulatory compliance processes for medical devices. If you have a strong background in Quality Assurance and Regulatory Affairs within the medical device industry and are looking for a challenging and rewarding opportunity to contribute to a growing company, this is the perfect fit. The Regulatory Affairs & Quality Manager position is responsible for maintaining and improving certifications such as ISO 13485 and FDA 21 CFR Part 820, as well as other relevant standards and regulations. The manager will oversee the Quality Management System (QMS), ensuring compliance and providing guidance, support, and training to the organization. Responsibilities: * Oversee the management of QMS, including CAPA processes, procedures, documentation, and records. * Manage the internal audit program to ensure compliance with legal, regulatory, and ISO standards. * Participate in external audits by regulatory agencies and certifying bodies. * Manage training programs on QMS, regulatory requirements, and quality control standards for employees. * Pursue continuous personal development and growth. * Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements. * Lead efforts to maintain ISO 13485 certification, including gap assessments, document preparation, and regulatory submissions. * Serve as a liaison on regulatory issues between LUCENT Surgical Solutions and LUCENT Surgical Solutions suppliers. * Participate in activities related to adverse events and recalls, including reporting, notification, and follow-ups. * Lead regular Management Review meetings to evaluate the overall performance of the QMS. * Coordinate and lead investigations into product quality failures, non-conformities, and customer complaints, ensuring prompt resolution and root cause analysis. * Maintain thorough, well documented records of all process/product monitoring activities * Adhere to safety requirements. * Maintain regular and punctual attendance. Education: * Bachelor's degree in a relevant field (e.g., Biological Sciences, Medical Technology, Quality Management, or Regulatory Affairs) required. Master's degree is a plus. Experience: * 2-5 years of relevant experience in an FDA and/or ISO regulated Quality or Regulatory position (Medical Device, Pharmaceutical, etc.). * Experience working within a compliant Quality Management System (QMS). * Experience with CAPA, internal and external audits, regulatory submissions preferred. Regulatory Knowledge: * Comprehensive understanding of GDP (Good Documentation Practices). * Proficiency in ISO 13485 standards. Knowledge of ISO 60601, IEC 62304, AAMI TIR101:2021, and FDA 21 CFR Part 820 regulations preferred. Certifications: * Certifications in Quality or Regulatory Affairs. CQA, ISO 13485:2016, RAC are a plus. Skills: * Ability to manage multiple projects and work independently with minimal supervision. * Demonstrated leadership, communication and human relation skills. * Proficiency in Microsoft Office. * Process improvement and evaluation skills. * Continuous learning mindset. * Strong organizational and time management abilities. * Able to implement and manage compliance programs. Job Type: Full-time Pay: $70,000.00 - $85,000.00 per year Benefits: * Dental insurance * Employee assistance program * Flexible schedule * Health insurance * Life insurance * Paid time off * Professional development assistance * Referral program * Vision insurance Schedule: * 8 hour shift Ability to Relocate: * Southfield, MI 48033: Relocate before starting work (Required) Work Location: In person