Document Control Manager, Quality Engineering

Analog Devices, Inc. • Wilmington, MA

45d • $144,000 - $198,000

About The Position

The MasterControl Document Control Manager will oversee managing ADI's document management systems with primary focus supporting the medical business, ensuring regulations compliance to standards on documented information (FDA, ISO, IATF), and streamlining quality processes. Key responsibilities include administering the MasterControl software, overseeing document lifecycles, coordinating change control, and leading a team of document control specialists. This role requires strong leadership, technical skills in electronic document management systems, and deep knowledge of relevant quality and regulatory requirements. This role offers a unique opportunity for candidates to expand their expertise with exposure to diverse ADI functions. Effective and efficient document control systems and teams strategically support faster to product launches, data integrity, and customer trust.

Requirements

• Experience managing document management systems, particularly MasterControl. Experience in SAP DMS or S4/HANA DMS is a plus.
• Strong knowledge of industry quality regulations and standards around document control and regulatory compliance (such as ISO9001, IATF 16949, ISO13485 or FDA 21 CFR Part 11).
• Experience developing and implementing document control processes and procedures.
• Experience in technical writing and quality control.
• Excellent organizational, time management, communication skills and collaboration skills with teams across various business units and geographies.
• Ability to lead and train teams utilizing best in class document management methodologies.
• Ability to manage competing priorities and adapt to change.
• Proven success in continuous improvement and streamlining processes with enhanced efficiency.
• B.S. degree in Engineering (Mechanical, Industrial, Electrical, or related field), Quality Assurance, or Computer Science, Business Management, Product Management, Medical, or equivalent experience.
• Minimum of 5 years of experience in document control or related field
• Experience managing a document management system, including document numbering, processing, distribution, and archiving.
• Experience managing a document control team.

Nice To Haves

• Experiencing transitioning to new document management systems is a plus.

Responsibilities

• Develop and manage document control procedures and electronic document management systems (EDMS) to ensure documents are accurate, complete, and consistent. Manage the MasterControl systems, including configuration, user training, and troubleshooting.
• Oversee the entire document control process, from creation and review to release and archival.
• Ensure all documentation meets internal standards and external regulatory requirements (such as ISO9001, IATF 16949, ISO13485 or FDA 21 CFR Part 11).
• Manage document change orders and ensure timely implementation of changes.
• Generate reports on document control activities, monitor systems for inefficiencies, and manage risks and opportunities. Assist in internal and external audits by coordinating documentation requests and providing support.
• Continuously improving document management processes for efficiency and effectiveness.
• Effectively communicate and influence change towards best-in-class document management processes based on document control principles to all employee levels. Coach, influence, and train not only the direct team but also stakeholders across the business to ensure cultural adoption.

Benefits

• This position qualifies for a discretionary performance-based bonus which is based on personal and company factors.
• This position includes medical, vision and dental coverage, 401k, paid vacation, holidays, and sick time, and other benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Computer and Electronic Product Manufacturing
• Number of Employees: 5,001-10,000 employees