Analog Devices, Inc

Senior Engineer, Quality Engineering

Analog Devices, Inc • $95K — $131K *
Wilmington, MA 01887In-Person
Healthcare
5 - 7 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • BS in Electrical, Mechanical, Biomedical, or related Engineering; MS preferred.
  • Experience in quality oversight throughout product development.
  • Proficient in quality systems and regulatory practices.
  • Familiar with FDA, ISO, GMP, and EU MDR requirements.
  • Experience with 510(k) and PMA submissions.
  • Skilled in quality tools like CAPA, Six Sigma, and statistical analysis.
  • Knowledgeable in risk management practices per ISO 14971.

Responsibilities

  • Drive improvements for the Medical Quality Management System to meet ISO and regulatory standards.
  • Lead quality system processes including CAPA, audits, and document control.
  • Develop and implement training for the quality management system.
  • Serve as expert during audits and lead readiness activities.
  • Analyze quality metrics to identify trends for improvements.
  • Provide input and leadership for regulatory submissions.
  • Ensure compliance with electronic record requirements and software validation.
  • Define and maintain design history and risk management documents.
  • Collaborate with teams across product lifecycle for integrated quality systems.
  • Mentor engineers on quality principles and continuous improvement.

Benefits

  • Medical, vision, and dental coverage.
  • 401(k) plan.
  • Paid vacation, holidays, and sick time.
  • Discretionary performance-based bonus.
Full Job Description
Job Summary
We are seeking an experienced and highly motivated Senior Medical Quality Engineer to join our dynamic team. This role plays a critical part in ensuring the quality, safety, and regulatory compliance of our medical product portfolio. The ideal candidate will bring deep experience in medical device quality systems, strong technical problem-solving skills, and the ability to partner effectively across engineering, regulatory, and operational teams.
Key Responsibilities
  • Drive strategic improvements and long-term planning for the Medical Quality Management System (MQMS) in alignment with ISO 13485, 21 CFR 820, EU MDR, and other applicable standards and regulations.
  • Lead the development, implementation, and governance of quality system processes including CAPA, Internal Audits, Document Control, Change Management, Training, and Management Review.
  • Own the training process architecture for MQMS, including development of training content, delivery strategy, and effectiveness monitoring across global teams.
  • Serve as a subject matter expert during internal and external audits, including FDA and Notified Body inspections, and lead audit readiness and response activities.
  • Analyze quality system performance metrics, identify systemic trends, and lead cross-functional initiatives to drive data-driven improvements.
  • Provide strategic input and technical leadership for regulatory submissions, including FDA 510(k), PMA, and EU MDR documentation.
  • Ensure compliance with 21 CFR Part 11 for electronic records and signatures, including validation and oversight of quality system software tools.
  • Lead the definition and maintenance of design history files, risk management documentation, and post-market surveillance processes.
  • Collaborate with R&D, Regulatory Affairs, Clinical, and Manufacturing teams to ensure seamless integration of quality systems throughout the product lifecycle.
  • Mentor and coach engineers and cross-functional partners on quality system principles, regulatory expectations, and continuous improvement methodologies.
  • Represent the Quality function in strategic forums and influence decision-making through expert guidance and system-level insights.
  • Lead root cause investigations and failure analysis efforts using advanced quality tools and methodologies, ensuring robust corrective and preventive actions.
  • Support validation planning and execution for new product designs and manufacturing processes, ensuring alignment with quality and regulatory requirements.
  • Provide leadership and support for FDA and other regulatory inspections, including pre-inspection readiness, real-time engagement, and post-inspection remediation.
Required Skills and Qualifications
  • BS in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Process
  • Engineering, or related technical disciplines. An MS degree is preferred.
  • Demonstrated experience in quality oversight and management of products through the lifecycle of product development.
  • Experience supporting quality systems, practices, and policies.
  • Familiarity with regulatory requirements including US CFR (Code of Federal Regulation), ISO (International Organization for Standardization), GMP (Good Manufacturing Practice), and EU MDR (Medical Device Regulation).
  • Knowledge of FDA 510(k) clearance, FDA Premarket Approval (PMA), and ongoing submission maintenance requirements.
  • Experience with the use of quality systems and tools (for example, CAPA, Six Sigma methodology, change control, Statistical Analysis, Control Plans, and document management)
  • Experience supporting Risk Management, for instance, ISO 14971 standard.
  • Experience directing root cause analysis using quality tools, such as 5 Why, Fishbone Analysis, and Fault Tree Analysis.


For positions requiring access to technical data, Analog Devices, Inc. may have to obtain export licensing approval from the U.S. Department of Commerce - Bureau of Industry and Security and/or the U.S. Department of State - Directorate of Defense Trade Controls. As such, applicants for this position - except US Citizens, US Permanent Residents, and protected individuals as defined by 8 U.S.C. 1324b(a)(3) - may have to go through an export licensing review process.

Job Req Type: Experienced

Required Travel: Yes, 10% of the time

Shift Type: 1st Shift/Days

The expected wage range for a new hire into this position is $95,600 to $131,450.
  • Actual wage offered may vary depending on work location, experience, education, training, external market data, internal pay equity, or other bona fide factors.
  • 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.

About Analog Devices, Inc

Analog Devices (NYSE: ADI) defines innovation and excellence in signal processing. ADI's analog, mixed-signal, and digital signal processing (DSP) integrated circuits (IC) play a fundamental role in converting, conditioning, and processing real-world phenomena such as light, sound, temperature, motion, and pressure into electrical signals to be used in a wide array of electronic equipment. But that doesn't begin to capture the essence of what Analog Devices does for their customers, and ultimately for the end user.

Analog Devices, Inc Careers

Joining Analog Devices, Inc (ADI) offers an unparalleled opportunity to be part of a team that prides itself on innovation, leadership, and a diverse and inclusive culture. As a global leader in the semiconductor industry, ADI is the perfect place to advance your career, whether you're a seasoned professional or just starting out. Work You’ll Do At Analog Devices, Inc, you will collaborate with some of the brightest minds in the industry, working on groundbreaking projects that shape the future of technology. Our commitment to innovation is unwavering, and we empower our team to explore new ideas and solutions. Be Part of a Great Team ADI is not just about individual achievements but about collective success. Our team culture is built on collaboration, where each member’s skills and insights are valued. We believe in nurturing our employees' growth through comprehensive professional and diversity training programs that foster an inclusive environment. Innovate and Lead Step into a role at ADI and you’ll find yourself at the intersection of technology and innovation. Our leadership in designing and manufacturing semiconductor products allows us to push boundaries and think outside the box. Your work here leads to the development of solutions that not only meet but exceed our clients' expectations. Career Growth and Opportunities Your career at Analog Devices, Inc is filled with endless possibilities. We offer a variety of job opportunities across multiple functions, ensuring that your career trajectory is in your hands. From engineering to marketing, and from sales to research and development, every position contributes to our global success. Internship Programs Start your career journey with an internship at ADI, where you can apply your academic knowledge in a real-world setting. Our internships provide a robust platform for learning and development, making you job-ready and equipped with practical skills that stand out in your resume. Benefits and Culture Choosing a career at Analog Devices, Inc means more than just employment. It signifies becoming part of a company that values your well-being and professional development. Our benefits package is designed to support not only your individual needs but also those of your family, encompassing health, finance, and work-life balance. Join Our Team Explore the job opportunities and open positions on our Careers page. We are continuously hiring new talents who are passionate, curious, and eager to make a difference. Sharpen your skills through our training programs and prepare for your interview with confidence. Networking and Professional Development At ADI, networking and professional development are part of our DNA. Engage with leaders and peers through various events and platforms, enhancing your career prospects and gaining insights that are integral to professional growth. Stay Connected Keep up to date with the latest at Analog Devices, Inc by following our Careers Blog. Gain insider perspectives and industry-leading insights that can help you navigate your career path at ADI. Job Alert Emails Personalize your subscription to receive job alerts and the latest news tailored to your preferences. Discover the exciting and rewarding career opportunities waiting for you at Analog Devices, Inc. Join Analog Devices, Inc today and be part of a company that thrives on innovation, values diversity, and is dedicated to your professional growth.
Learn more about Analog Devices, Inc
Size
24,700 employees
Market Cap
$82.5 billion
Industry
Manufacturing & Automotive
Net Income
$1.4 billion
Founded
1965
5 Year Trend
+18%
Revenue
$5.8 billion
NASDAQ
ADI
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Analog Devices, Inc

More Healthcare Jobs

Find similar Senior Engineer, Quality Engineering jobs:

NationwideWilmington, MA