Quality Systems Manager

Accountabilities: In this role, you will lead Quality Systems activities, support regulatory compliance, and promote continuous improvement across internal teams and external partners. Your responsibilities will include: Quality Management System Oversight: Manage Quality Systems activities in accordance with organizational policies and applicable medical device regulations and standards. Cross-Functional Collaboration: Serve as the primary Quality Systems contact for internal stakeholders, supporting coordination with corporate Quality, Regulatory, Operations, and Clinical teams. Physician Communications: Manage communications with physicians regarding returned product analysis test results. Product Quality and Distribution: Lead and support cross-functional teams to ensure product quality and distribution activities comply with regulatory requirements, industry standards, and internal procedures. Process Management and Improvement: Implement, maintain, and improve quality processes and procedures, including internal audits, change management, supplier quality, clinical research quality, complaint handling, and document control. External Partner Management: Manage external contract design and manufacturing organizations (CMDOs) in collaboration with the sourcing team. Performance Monitoring: Track departmental goals, metrics, and performance indicators to ensure quality objectives are achieved. Resource Planning: Support resource planning and provide input into departmental and organizational budgets and staffing requirements. Quality and Compliance Awareness: Promote understanding of regulatory, quality, and customer requirements throughout the organization. Risk Management: Identify and communicate potential quality and compliance risks, recommending appropriate corrective actions. Regulatory Compliance: Support the maintenance and improvement of compliance with FDA 21 CFR Part 820 Quality Management System Regulation (QMSR), ISO 13485, and other applicable requirements across internal and external sites. Audits and Inspections: Lead internal and external audits and support inspections conducted by regulatory agencies and notified bodies. Continuous Improvement: Drive initiatives to strengthen Quality Systems processes, compliance activities, and overall operational effectiveness. Requirements The ideal candidate will combine a solid technical background with practical experience in quality management within a regulated medical device, pharmaceutical, or biomedical environment. Strong analytical, communication, and influencing skills are essential, along with the ability to manage competing priorities. The qualifications include: Bachelor's degree in Engineering, Computer Science, Physics, Life Sciences, or a related technical field. An advanced degree is preferred. 5–10 years of experience in a medical device, pharmaceutical, biomedical, or other regulated quality environment. Experience supporting quality engineering activities within a regulated product environment. Strong understanding of risk management, supplier quality, complaint management, and Quality Management System requirements. Ability to communicate technical and regulatory requirements effectively across different organizational levels. Familiarity with configuration and change management practices. Demonstrated ability to influence cross-functional stakeholders and manage competing priorities. Strong analytical, organizational, and problem-solving skills. Excellent written and verbal communication skills. Working knowledge of FDA regulations, including 21 CFR Parts 11, 801, 803, 806, 807, 812, 820, 822, and 830. Working knowledge of ISO 13485 and medical device Quality Management Systems. Understanding of Good Manufacturing Practice (GMP) requirements. Knowledge of quality processes throughout the product lifecycle. Understanding of statistical methods and quality improvement tools. Strong engineering and technical aptitude across hardware, software, and systems development environments. Experience supporting regulatory submissions, audits, and inspections is preferred. Nice to have: Experience participating in regulatory inspections and third-party audits. Relevant professional certification, such as ASQ Certified Quality Manager (CQM), Certified Quality Engineer (CQE), or equivalent. ISO 13485 Lead Auditor or ASQ Certified Quality Auditor (CQA) qualification. Additional role details: No direct reports; the role leads cross-functional contributors through expertise and influence. Full-time position, Monday through Friday, with working hours potentially varying according to the time zones supported. Occasional evening or weekend work may be required depending on business needs. Limited, occasional travel for specific projects, meetings, or events. Primarily based in a professional office or remote office environment, with occasional participation in supplier-related activities and events. Requires regular mobility, frequent use of computers and mobile devices, and the ability to communicate and collaborate effectively over extended periods. Reasonable accommodations may be made for individuals with disabilities. Benefits Work Arrangement: Remote position based out of Lake Oswego, Oregon. Employment Type: Full-time, permanent position. Working Schedule: Standard Monday-to-Friday schedule, with hours adapted to the time zones supported. Travel: Limited and occasional travel for assigned projects, meetings, or events. Equal Opportunity: All qualified applicants receive consideration without discrimination based on legally protected characteristics.