Senior Engineer, Quality Engineering

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

Benefits offered by this job

Medical coverage

Vision & Dental

401k

Paid time off

Job summary

Analog Devices, Inc. is seeking an experienced Senior Medical Quality Engineer to ensure the quality, safety, and regulatory compliance of our medical product portfolio.

You will lead MQMS improvements, audits, and regulatory submissions while partnering with R&D, Regulatory, and Manufacturing teams. The role requires deep experience in medical device quality systems and data-driven problem solving, with responsibilities spanning training, CAPA, document control, and change management within a

Qualifications

• BS in Electrical, Mechanical, Biomedical Engineering, Process Engineering, or related technical disciplines; MS preferred.
• Experience in quality oversight and lifecycle product development.
• Familiarity with US CFR, ISO, GMP, and EU MDR requirements; knowledge of FDA 510(k) and PMA.
• Experience with quality systems/tools: CAPA, change control, statistics, control plans, docs management.
• Experience with ISO 14971 risk management and root-cause analysis methods.

Responsibilities

• Lead MQMS improvements aligned with ISO 13485, 21 CFR 820, EU MDR.
• Develop and govern quality system processes (CAPA, audits, document control, training).
• Own MQMS training architecture and effectiveness across global teams.
• Lead audits including FDA and Notified Body inspections, audit readiness.
• Analyze quality metrics, identify trends, drive cross-functional improvements.
• Contribute to regulatory submissions (FDA 510(k), PMA, EU MDR).
• Ensure 21 CFR Part 11 compliance for electronic records and signatures.
• Define/design DHF, risk management docs, and post-market surveillance.
• Collaborate with R&D, Regulatory, Clinical, Manufacturing.
• Mentor engineers on quality system principles and regulatory expectations.
• Lead root cause investigations using quality tools (5 Why, Fishbone, FTA).
• Support validation planning/execution for new designs and processes.
• Assist in FDA inspections, pre-inspection readiness, and remediation.

Skills

Quality oversight

Regulatory knowledge

Root cause analysis

Process improvement

Education

BS in Engineering

MS degree preferred

Tools

CAPA

Six Sigma

Change control

Statistical analysis

Document management

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.