Senior Engineer, Quality Engineering

Analog Devices, Inc.; Wilmington (MA); On-site; USD 96,000 - 131,000; Full time

Job summary

Analog Devices, Inc. seeks an experienced Senior Medical Quality Engineer to ensure quality, safety, and regulatory compliance of its medical product portfolio. The role partners with engineering, regulatory, and operations to drive quality across the product lifecycle.

The ideal candidate brings deep MQMS experience, strong problem‑solving, and leadership in audits, CAPA, and process improvements in a global environment. This position offers competitive compensation and comprehensive benefits.

Qualifications

• CAPA, Internal Audits, Document Control, Change Management experience.
• Process Quality systems knowledge incl. CAPA, Risk Management, audits.
• Familiarity with regulatory requirements (FDA, ISO, EU MDR).
• Experience with FDA 510(k)/PMA and EU MDR submissions.

Responsibilities

• Drive MQMS improvements aligned with ISO 13485, 21 CFR 820, EU MDR and other standards.
• Lead quality system processes including CAPA, Internal Audits, Document Control, Change Management, Training and Management Review.
• Own MQMS training architecture, content, delivery, and effectiveness across global teams.
• Serve as SME during audits, including FDA and Notified Body inspections, and manage audit readiness.
• Analyze quality system performance metrics and lead data-driven improvements across functions.
• Provide strategic input for regulatory submissions (FDA 510(k), PMA, EU MDR).
• Ensure 21 CFR Part 11 compliance for electronic records and QA software tools.
• Lead DHF/risk management documentation and post-market surveillance maintenance.
• Collaborate with R&D, Regulatory, Clinical, and Manufacturing to integrate quality systems.
• Mentor engineers on quality principles and continuous improvement methodologies.
• Represent Quality in strategic forums and guide system-level decisions.
• Lead root cause investigations using quality tools (5 Why, Fishbone, FTA).
• Support validation planning/execution for new designs and manufacturing processes.
• Assist in FDA inspections and post-inspection remediation.

Skills

CAPA

Internal Audits

Document Control

Change Management

Training

Management Review

FDA inspections

Regulatory submissions

21 CFR Part 11

Risk Management ISO 14971

Data-driven improvements

Education

BS in Electrical Engineering

MS preferred

Job description

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, AI, and software technologies into solutions that combat climate change, reliably connect humans and the world, and help drive advancements in automation and robotics, mobility, healthcare, energy and data centers. With revenue of more than $11 billion in FY25, ADI ensures today's innovators stay Ahead of What's Possible. Learn more at www.analog.com and on LinkedIn and X.

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.
• Analog Devices is an equal opportunity employer.
• We foster a culture where everyone has an opportunity to succeed regardless of their race, color, religion, age, ancestry, national origin, social or ethnic origin, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, parental status, disability, medical condition, genetic information, military or veteran status, union membership, and political affiliation, or any other legally protected group.
• EEO is the Law: Notice of Applicant Rights Under the Law.

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.

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, AI, and software technologies into solutions that combat climate change, reliably connect humans and the world, and help drive advancements in automation and robotics, mobility, healthcare, energy and data centers. With revenue of more than $11 billion in FY25, ADI ensures today's innovators stay Ahead of What's Possible. Learn more at www.analog.com and on LinkedIn and X. Come join ADI – a place where Innovation meets Impact. For more than 55 years, Analog Devices has been inventing new breakthrough technologies that transform lives. At ADI you will work alongside the brightest minds to collaborate on solving complex problems that matter from autonomous vehicles, drones and factories to augmented reality and remote healthcare. ADI fosters a culture that focuses on employees through beneficial programs, aligned goals, continuous learning opportunities, and practices that create a more sustainable future.