Position Overview:

We are seeking a Quality Management Systems Specialist to assist with a major project in Oneonta, focusing on changes to the documentation system and preparing for an upcoming audit. The ideal candidate will have experience in quality management systems, internal auditing, and regulatory compliance, particularly in manufacturing environments.

Key Responsibilities:

• Generate, review, and maintain division-level quality system documents (e.g., procedures, work instructions, job aids, certificates of conformance) in compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.
• Initiate Change Controls and Document Change Requests to update procedures and processes, collaborating with manufacturing and distribution sites to assess impacts on processes.
• Monitor and assess quality system metrics to ensure compliance.
• Act as the lead auditor for the division’s internal audit program.
• Assist in completing quality projects and use root cause analysis to support the completion of Corrective and Preventive Actions (CAPAs).
• Lead or support continuous improvement initiatives for quality management system processes.
• Assist with regulatory activities.
• Perform other duties as required.

Minimum Qualifications:

• Associates or Bachelor’s Degree, or 3+ years of equivalent work experience (preferably in a manufacturing environment).

Preferred Skills & Experience:

• Previous experience using ETQ or other document management software.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Experience with ISO 9001 or other Quality System standards.
• Knowledge of ISO 13485 and 21 CFR 820 Quality Management Systems (highly preferred).
• Internal audit experience and/or training.
• Strong attention to detail and accuracy in work execution.
• Ability to apply basic mathematical concepts (percentages, ratios, and proportions).
• Ability to work effectively across matrix organizations and collaborate with external consultants.
• Ability to take ownership of assignments and proactively consult with team members or other departments for guidance as needed.

Benefits:

• As per Pay Transparency laws, employers should include a general description of any health or compulsory benefits. (Note: Benefits details should be added here if applicable).