Quality Engineer

Overview: We are seeking an experienced Quality Management Specialist to join our team in Oneonta, NY. This role will focus on supporting a major project to update our documentation system and prepare for an upcoming audit. The ideal candidate will bring expertise in quality management systems (QMS), including experience in ISO 9001, ISO 13485, and 21 CFR 820 standards. Key Responsibilities: Document Control & Compliance: Generate, review, and maintain division-level quality system documents such as procedures, work instructions, and job aids, ensuring compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards. Change Management: Initiate and manage Change Controls and Document Change Requests to update procedures and processes. Collaborate with manufacturing and distribution teams to assess the impact of changes. Quality Metrics: Assist in monitoring and analyzing quality system metrics to ensure compliance with regulatory requirements. Internal Auditing: Act as a lead auditor for internal audits, ensuring processes and systems align with quality standards. Continuous Improvement: Support and lead continuous improvement initiatives within the Quality Management System (QMS). Regulatory Support: Assist with regulatory activities and ensure compliance with relevant laws and regulations. Root Cause Analysis: Use root cause analysis to assist in completing Corrective and Preventive Actions (CAPAs) and other quality projects. Qualifications & Experience: Education: Associate’s or Bachelor’s degree in a related field. Experience: 3 years of relevant work experience (experience in a manufacturing environment is ). Software Proficiency: Experience using ETQ or other Document Management software is a plus. Quality Management Standards: Strong knowledge of ISO 9001 and other Quality System standards; ISO 13485 and 21 CFR 820 knowledge highly . Internal Auditing: Experience with internal auditing or related training is required. Attention to Detail: Must be highly detail-oriented with the ability to execute tasks accurately and efficiently. Cross-Functional Collaboration: Proven ability to work across teams and with external consultants to drive projects to completion. Mathematical Skills: Ability to apply basic mathematical concepts (percentages, ratios, proportions) to practical situations. Ownership: Able to take ownership of assignments and proactively consult with team members and departments as necessary.