Quality Engineer 1 (Document Control)

Merck • Bedford, MA

40d • $82,100 - $123,100

About The Position

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your Role: 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level