Quality Engineer 1 (Document Control)

Merck KGaA•Bedford, MA

40d

About The Position

MilliporeSigma is seeking a motivated and detail-oriented Quality Engineer 1 to join our team in Bedford, MA. In this role, you will play a critical part in supporting our documentation system and various quality aspects, including quality assurance, regulatory compliance, document control, training and support, continuous improvement, and audit preparation. You will be responsible for managing the lifecycle of documents, ensuring their accuracy, consistency, and compliance with regulatory requirements.

Requirements

Bachelor's degree in any field
1+ year of experience in quality documentation or quality engineering
1+ year of experience with quality management systems and regulatory standards, particularly ISO 9001:2015

Nice To Haves

Bachelor's degree in Quality Assurance, Engineering, or Scientific discipline
Experience using an electronic QMS system
Knowledge or experience in product development processes
Certification as a Quality Engineer (CQE) from the American Society for Quality (ASQ)
Understanding of quality management systems and their implementation
Proficiency in Microsoft Office Suite and quality systems software
Excellent interpersonal, written, and verbal communication skills
Strong attention to detail and excellent organizational skills
Ability to work independently, manage time effectively, and meet deadlines

Responsibilities

Document Control: Maintain a comprehensive document control system, overseeing the issuance, distribution, and retrieval of documents while ensuring accurate records of changes and approvals.
Collaboration: Work closely with various departments to ensure document accuracy and availability, responding promptly to document requests and inquiries.
Training and Support: Provide training and support to employees on document control procedures to promote a culture of quality awareness.
Audit Assistance: Assist with site-specific ISO 9001:2015 audits, including scheduling, preparation, gathering resolution evidence, and ensuring timely closure of audit findings in the management system.
Documentation Management: Draft and update procedures, flowcharts, and visuals as required to support documentation management efforts.
Quality Initiatives: Support other quality-related activities and initiatives as needed to enhance overall quality processes.