Quality Management System Specialist II

Kls-Martin-Group; Jacksonville (FL); Hybrid; USD 80,000 - 110,000; Full time

Job summary

KLS-Martin-Group seeks a Quality Management System Specialist II to drive the QMS for medical devices, lead complex processes, audits, and risk-based improvements across functions in a largely on-site role with local remote work.

You will manage documents in SharePoint, draft procedures, oversee CAPA, audits including MDSAP, analyze quality data, and mentor junior team members while ensuring regulatory compliance with ISO 13485 and FDA requirements.

Qualifications

• 4-year degree plus 3–5 years in a regulated industry, or 5+ years in regulated industry.
• Regulatory knowledge of ISO 13485 and FDA.
• Proficient with Microsoft Office and intermediate Excel.
• Ability to communicate effectively with all levels and solve problems.

Responsibilities

• Support the administration, maintenance, and continual improvement of the QMS at KLS.
• Lead implementation and monitoring of assigned QMS processes and improvement initiatives.
• Manage complex QMS records, projects, and action items.
• Support recalls and advisory notices and coordinate activities.
• Plan, conduct, and follow up on risk-based audits, including MDSAP audits.
• Coordinate audit evidence and minutes with observations, commitments, and owners.
• Oversee document management and SharePoint libraries.
• Draft, review, and approve quality documents and procedures.
• Lead corrective and preventive actions and investigations.
• Lead Management Review meetings and analyze quality data trends.
• Assist with calibration and supplier control activities.

Skills

Regulatory knowledge

MS Excel

Interpersonal skills

Communication skills

Independent work

Education

Bachelor's degree

Tools

SharePoint

Job description

Job SummaryThe 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 responsibilitiesSupport 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 RequirementsKnowledge of device regulations and device applications ISO 13485, FDA, SOR 98 2824 year degree plus 3 to 5 years of work experience in a regulated industry or5 years of experience in regulated industryProficient user of Microsoft Office applications, with intermediate knowledge of MS ExcelKnowledge, Skills, and AbilitiesMaintains high integrity and confidentiality of company and department informationAbility to work effectively with all levels of internal and external associates, customers, and colleaguesExcellent interpersonal skills with the ability to effectively communicate at all levels internally as well as externallyAbility to follow through on issues, make informed decisions that comply with policies and procedures, complete tasks and problem solveAbility to retrieve and interpret documentationAbility to work with minimal supervisionAbility to manage multiple prioritiesAbility to work both independently and within a team environment