Quality Management System Specialist II

Job Summary

The Quality Management System Specialist II supports the development, implementation, maintenance, and continual improvement of the Quality Management System for medical devices. This role independently leads complex assigned QMS processes, evaluates quality system needs and risks, leads and supports audits, analyzes quality data, and partners with cross-functional teams to implement practical, compliant improvements. The position provides technical guidance and supports the development of lower-level QMS team members. This position requires flexible hours to support, monitor, and ensure regulatory compliance. Additionally, the position will require both onsite and local remote work.

Essential Functions, Duties, and responsibilities

• Support the administration, maintenance, and continual improvement of the Quality Management System (QMS) at KLS.
• Lead implementation and monitoring of assigned QMS processes, procedures, quality plans, and improvement initiatives.
• Independently manage complex or multiple assigned QMS processes, records, projects, and action items.
• Support recalls and advisory notices, including coordination of assigned activities.
• Maintains and applies current knowledge of FDA and international regulations, guidance, and standards applicable to company products (medical devices).
• Plan, conduct, document, and follow up on risk-based process audits, and lead or support internal and external audits, including MDSAP audits.
• Coordinate audit evidence and capture accurate and timely minutes during audits, including observations, commitments, action owners, and due dates.
• Provide oversight of assigned document management activities and SharePoint libraries.
• Draft, review, and approve quality documents and procedures.
• Evaluate, document and communicate QMS impacts and recommend appropriate actions or controls.
• Provide oversight and support for assigned calibration and supplier control activities.
• Lead assigned corrective and preventive action, nonconformity, investigation, and effectiveness-check activities.
• Lead planning and preparation of Management Review meetings.
• Analyze, trend, and communicate quality system data (i.e., NCMRs, Adverse Events, Supplier Ratings, etc.)
• Perform other related duties as assigned.

Education and Experience Requirements

• Knowledge of device regulations and device applications ISO 13485, FDA, SOR 98 282

• 4 year degree plus 3 to 5 years of work experience in a regulated industry or
• 5 years of experience in regulated industry
• Proficient user of Microsoft Office applications, with intermediate knowledge of MS Excel

Knowledge, Skills, and Abilities

• Maintains high integrity and confidentiality of company and department information
• Ability to work effectively with all levels of internal and external associates, customers, and colleagues
• Excellent interpersonal skills with the ability to effectively communicate at all levels internally as well as externally
• Ability to follow through on issues, make informed decisions that comply with policies and procedures, complete tasks and problem solve
• Ability to retrieve and interpret documentation
• Ability to work with minimal supervision

• Ability to manage multiple priorities
• Ability to work both independently and within a team environment