Sr. Medical Quality Engineer

4 days ago

Wilmington, MA, United States Analog Devices Full time
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).

Job Summary: We are seeking an experienced Sr. Quality Engineer to join our dynamic team in the medical device industry. The ideal candidate will have a strong background in computer software validations, quality systems, and a deep understanding of regulatory requirements. This role is critical in ensuring the quality and compliance of our medical devices, contributing to the development and maintenance of our quality management system.

Key Responsibilities:
  • Develop, implement, and maintain computer software validation assurance processes and procedures.
  • Conduct software validation activities in accordance with regulatory standards (e.g., FDA, ISO 13485).
  • Collaborate with cross-functional teams to ensure product development and validation activities meet quality and compliance requirements.
  • Perform risk assessments and develop mitigation strategies for software-related issues.
  • Review and approve software and quality documentation, including validation plans, protocols, reports, standard operating procedures (SOPs), and work instructions.
  • Support root cause analysis and implement corrective and preventive actions (CAPA) to address quality issues.
  • Support the investigation and resolution of customer complaints and non-conformances.
  • Participate in internal and external audits, ensuring compliance with regulatory standards.
  • Monitor and analyze quality metrics to identify trends and areas for improvement.
  • Provide training and support to team members on quality and validation processes.
Qualifications:
  • Bachelor's degree in Computer Science, Engineering, or a related field.
  • Minimum of 5 years of experience in software quality engineering, preferably in the medical device industry.
  • Proven experience in computer software validations and familiarity with regulatory requirements (e.g., FDA 21 CFR Part 11, ISO 13485).
  • Strong understanding of software development life cycle (SDLC) and quality assurance methodologies.
  • Experience supporting quality management systems, CAPA processes, and change controls.
  • Excellent problem-solving skills and attention to detail.
  • Strong communication and interpersonal skills.
  • Ability to work effectively in a team environment and manage multiple projects simultaneously.
Preferred Qualifications:
  • Advanced degree in a related field.
  • Certification in quality engineering, software quality engineering (e.g., ASQ CQE, CSQE).
  • Experience with automated testing tools and techniques.
  • Knowledge of cybersecurity principles as they apply to medical device software.


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 $94,000 to $129,250.
  • 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.

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