Document Control Manager, Quality Engineering

Analog Devices-posted 13 days ago

$144,000 - $198,000/Yr

Full-time • Mid Level

Wilmington, MA

5,001-10,000 employees

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About Analog Devices Analog Devices, Inc. (NASDAQ: ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world. With revenue of more than $9 billion in FY24 and approximately 24,000 people globally, ADI ensures today's innovators stay Ahead of What's Possible™. Learn more at www.analog.com and on LinkedIn and Twitter (X) . Come to join Analog Devices – a place where Innovation meets Impact. For the past 50 years, Analog Devices has been inventing innovative technologies that transform lives. Get firsthand experience working with the brightest minds to solve complex problems that matter from autonomous vehicles, drones, and factories to augmented reality and remote healthcare. Enjoy a culture that values aligned goals, balance, continuous learning throughout your career and shared rewards. At ADI, we invest in you and succeed together because we believe that happy, healthy, intellectually engaged people drive our growth and market leadership. ADI helps customers bridge the physical and digital worlds with unmatched technologies that solve real-live problems and make the world smarter, healthier, greener, and safer. With over $5 billion in revenue, ADI specializes in high-performance analog, mixed-signal, power, and digital signal processing (DSP) integrated circuits that sense, measure, interpret, connect, power, secure and transform how the world experiences the world around them. 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.

System Management / Software administration: 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.
Document lifecycle management: Oversee the entire document control process, from creation and review to release and archival.
Compliance and quality: Ensure all documentation meets internal standards and external regulatory requirements (such as ISO9001, IATF 16949, ISO13485 or FDA 21 CFR Part 11).
Change control: Manage document change orders and ensure timely implementation of changes.
Reporting and Auditing: 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.
Process improvement: Continuously improving document management processes for efficiency and effectiveness.
Change Leadership: 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.

We are seeking an enthusiastic MasterControl Document Control Manager with excellent attention to detail and accuracy with the ability to analyze and interpret data.
Experience managing document management systems, particularly MasterControl.
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.
In addition, since it will be necessary to engage with all levels of the organization globally, the ideal candidate will need to demonstrate effective communication and collaboration skills, and an appetite for learning (such as staying ahead of regulatory trends or technology innovations in document management).
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.

Experience in SAP DMS or S4/HANA DMS is a plus.
Experiencing transitioning to new document management systems is a plus.

This position includes medical, vision and dental coverage, 401k, paid vacation, holidays, and sick time , and other benefits.

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