Director, Quality Systems

Get AI-powered advice on this job and more exclusive features. Founded in 1976 and headquartered in Redmond, Washington, MicroSurgical Technology's passion is creating exceptional surgical devices and instruments used to restore or improve sight for patients all over the world. MST is part of UK based Halma PLC, a global company whose healthcare division helps provide technologies and solutions that enhance the quality of patients’ lives. Our products are surgeon-designed and meticulously crafted to instill confidence and assurance in Cataract and Glaucoma procedures and include a wide range of surgical instruments such as forceps, scissors, hooks, spatulas, and knives, all designed for the delicate and intricate procedures required in microsurgery. Together, we create a place where we are successful, motivated by our mission and inspire each other. This is where you can do your best work! Director, Quality Systems Location – Redmond, WA Job Summary: The Director, Quality Systems has primary responsibility for the development, implementation, and improvement of the MST Quality Management System (QMS) overseeing all aspects of Quality, including Document Control, QA Inspection, Quality Engineering and other Quality Support functions. The Director, Quality Systems has exceptional leadership, technical and change management skills to deliver superior results and foster a culture of quality. Key Responsibilities: Act as the Management Representative and PRRC (as necessary), performing the required duties governed by regulations and standards. Provide leadership and guidance in the maintenance and continuous improvement of processes/programs related to document control and change management, CAPA, NCR, audits, management review, design and development, risk management, process validation and supplier management. Lead the development, implementation, and continuous improvement of the QMS to ensure compliance with applicable regulatory requirements and relevant international standards (e.g. ISO 13485, MDSAP, EU MDR, FDA QSR/QMSR, etc.). Monitor, analyze, and report on QMS effectiveness and compliance metrics to executive leadership through management review. Lead and facilitate management review, ensuring all required inputs/outputs are addressed. Ensure quality policy and quality objectives are developed, maintained and effective. Manages Internal Audit Program and ensures there is adequate resourcing to conduct audits. Ensure the QMS and business are in a state of audit readiness. Serve as a key point of contact for external audits and regulatory inspections; manage responses to audit observations and ensure effective corrective actions. Oversee supplier audits and monitor supplier performance to ensure compliance with quality requirements. Oversee the Corrective and Preventive Action (CAPA) system, ensuring timely investigation, root cause analysis, and effective implementation of corrective/preventive actions. Oversee and assist in the administration of document and change control, including the eQMS. Champion digital transformation initiatives (as applicable) to enhance quality process efficiencies. Facilitate cross-functional improvement projects that enhance QMS processes, reduce waste, and promote best practices. Partner with R&D, Manufacturing Engineering, Production, Supply Chain, Regulatory Affairs, and other departments to ensure product and process compliance throughout the product lifecycle. Provide guidance on Standard Operating Procedures (SOPs), work instructions and other QMS documents. Serve as the go-to Subject Matter Expert (SME) in all aspects of Quality. Provide training and mentorship for quality processes. Lead or assist in the selection and implementation of software tools that impact the QMS. Mentor and manage direct reports, fostering professional growth and knowledge sharing within the Quality department. Promote a strong quality culture across the organization. Stay abreast with evolving regulatory requirements, standards, and best practices. Interpret and communicate regulatory changes to internal stakeholders and ensure timely updates to quality processes and documentation. Serve as a key point of contact for quality-related matters in contract manufacturing partnerships. Perform other duties as required. Qualifications: Bachelor’s degree in engineering, life sciences, or a related field. A master’s degree is strongly preferred. Minimum of 10 years of experience in Quality Assurance or Quality Systems within the medical device or similarly regulated industry. Minimum of 3 years of experience in a management role. Relevant quality certifications (e.g. internal auditing, CQE, Six Sigma, etc.) are advantageous. In-depth knowledge and proven track record of implementing and managing QMS elements in compliance with FDA 21 CFR 820, ISO 13485, MDSAP, EU MDR, ISO 14971, ISO 24971 and other applicable regulations. Experience leading internal and external audits; strong understanding of audit methodologies and CAPA management. Strong analytical, problem-solving, and project management skills; experience with data analysis tools (e.g., Lean, Six Sigma) is preferred. Proficient in quality management software systems and document control platforms. Excellent communication and presentation skills, with the ability to collaborate effectively across departments and levels. Demonstrated success in driving continuous improvement initiatives and organizational change. Ability to balance strategic planning with day-to-day operational responsibilities. High attention to detail, with strong organizational and time management capabilities. Demonstrated capability to influence and drive strategy and key decision making. Energy and enthusiasm for helping patients, surgeons and making MST a great place to work. Salary Range: DOE $150-190K The salary range listed in this posting reflects the compensation for a successful candidate in the assigned geographic territory. The successful candidate’s actual pay will be based on various factors such as skills, qualifications and experience. This role is eligible for a competitive benefits package that includes medical, dental, vision, life, and disability insurance; 401K retirement plan; flexible spending and health savings account; paid holidays; paid time off; parental leave; employee assistance program and other company benefits. MicroSurgical Technology Inc. is an equal opportunity employer and does not discriminate based on gender, sex, age, race and color, religion, marital status, national origin, disability, sexual orientation, gender identity or expressions, veteran status, or any other category that is protected by applicable law. Please note that only qualified candidates will be contacted for further consideration. Seniority level

Seniority level Mid-Senior level Employment type

Employment type Full-time Job function

Job function Quality Assurance and Manufacturing Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at MicroSurgical Technology by 2x Get notified about new Director Quality System jobs in

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