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Randstad US qa engineer in andover, Massachusetts

qa engineer.

  • andover , massachusetts

  • posted june 22, 2022

job details

summary

  • $38 - $43 per hour

  • contract

  • bachelor degree

  • category computer and mathematical occupations

  • reference935895

job details

job summary:

Job Description

In this role, you have the opportunity to

Support New Product Development projects within Image Guide Therapy with respect to software, firmware, and hardware from a software design quality assurance perspective.

You are responsible for

  • Leading the creation and review of risk management file to include the risk management plan, product hazard analysis, FMEAs, Software Risk Assessment, Risk Management Matrix, and Benefit Risk Determination.

  • Ensuring Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, etc. Expertise in ISO 14971, Risk Management for medical devices and IEC 62304 Medical Device Software.

  • Support in the creation and review of all medical device software documentation including cyber security assessments such as Data Protection, Privacy, and Security Assessments etc.

  • Understanding of all aspects of the QMS related to Design Controls. 21 CFR 820, ISO 13485

  • Development and status reporting of Quality and Reliability metric during phase reviews.

  • Participate in Design Verification Planning, Protocol Review, Report Review.

  • Participate in Design Validation Planning, Protocol Review, Report Review.

  • Participate in Process Validation Planning, Protocol Review, Report Review.

  • Provide Guidance on Quality aspects of PDLM Deliverables in addition to Design Verification/Validation.

To succeed in this role, you should have the following skills and experience

  • Electrical, Computer/Software, or Biomedical Engineering degree.

  • 3+ years of software quality or electrical engineering experience.

  • ASQ-CQE preferred.

  • Expertise in ing IEC 60601 and working knowledge with IEC 62304 and other relevant medical device standards

  • Knowledge in electrical and electronic manufacturing processes

  • Experience with software development lifecycle mythologies including Agile and SAFe

  • Familiar with software tools:

  • Defect tracking and management tools such a Jira or Clearquest.

  • Statistical software solutions such as JMP or Minitab

  • Design for reliability concepts and relating complaint history to reliability goals on new projects

  • strong leadership skills and ability to work in a team environment

  • Highly motivated hands-on engineer with a proven record of meeting timelines and goals

  • Must possess strong analytical & problem-solving skills

  • Non-Product Software Validation, IQ OQ PQ

  • Non-conforming product investigation, issue and defect tracking, CAPA

  • Post Market Surveillance and complaint review

  • Job Posting Description

In this role, you have the opportunity to

Support New Product Development projects within Image Guide Therapy with respect to software, firmware, and hardware from a design quality assurance perspective.

You are responsible for

  • Lead and support the creation and review of risk management file to include the risk management plan, product hazard analysis, FMEAs, Software Risk Assessment, Risk Management Matrix, and Benefit Risk Determination.

  • Ensuring Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, etc. Expertise in ISO 14971, Risk Management for medical devices and IEC 62304 Medical Device Software.

  • Support in the creation and review of all medical device documentation including cyber security assessments such as Data Protection, Privacy, and Security Assessments etc.

  • Understanding of all aspects of the QMS related to Design Controls. 21 CFR 820, ISO 13485

  • Development and status reporting of Quality and Reliability metric during phase reviews.

  • Participate in Design Verification Planning, Protocol Review, Report Review.

  • Participate in Design Validation Planning, Protocol Review, Report Review.

  • Participate in Process Validation Planning, Protocol Review, Report Review.

  • Provide Guidance on Quality aspects of PDLM Deliverables in addition to Design Verification/Validation.

You are a part of

Our solutions combine navigational tools such as catheters and guide wires with advanced software to help confirm the optimal treatment at the point of care: measurement technology, procedure-specific application support and on-board imaging and monitoring with improved anatomical and functional information to optimize therapy delivery. The IGT Devices organization consists of three segments: Coronary, Peripheral Vascular and Electrophysiology.

To succeed in this role, you should have the following skills and experience

  • US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

  • Engineering or related Science degree.

  • 3+ years of quality engineering experience.

  • ASQ-CQE preferred.

  • Graduate degree in Engineering/Science preferred.

  • Expertise in ing ISO 13485, ISO 14971, IEC 60601 and working knowledge with IEC 62304 and other relevant medical device standards.

  • Knowledge in manufacturing processes

  • Experience with medical device development lifecycle mythologies including Agile and SAFe preferred.

  • Familiar with systems engineering tools including software tools such as, design traceability, defect tracking and management tools such a Jira or Clearquest.

  • Statistical software solutions such as JMP or Minitab

  • Design for reliability concepts and relating complaint history to reliability goals on new projects

  • strong leadership skills and ability to work in a team environment

  • Highly motivated hands-on engineer/scientist with a proven record of meeting timelines and goals

  • Must possess strong analytical & problem-solving skills

  • Knowledge of Non-Product Software Validation, IQ OQ PQ

location: ANDOVER, Massachusetts

job type: Contract

salary: $38 - 43 per hour

work hours: 8am to 4pm

education: Bachelors

responsibilities:

Leading the creation and review of risk management file to include the risk management plan, product hazard analysis, FMEAs, Software Risk Assessment, Risk Management Matrix, and Benefit Risk Determination.

  • Ensuring Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, etc. Expertise in ISO 14971, Risk Management for medical devices and IEC 62304 Medical Device Software.

  • Support in the creation and review of all medical device software documentation including cyber security assessments such as Data Protection, Privacy, and Security Assessments etc.

  • Understanding of all aspects of the QMS related to Design Controls. 21 CFR 820, ISO 13485

  • Development and status reporting of Quality and Reliability metric during phase reviews.

  • Participate in Design Verification Planning, Protocol Review, Report Review.

  • Participate in Design Validation Planning, Protocol Review, Report Review.

  • Participate in Process Validation Planning, Protocol Review, Report Review.

  • Provide Guidance on Quality aspects of PDLM Deliverables in addition to Design Verification/Validation.

qualifications:

  • Experience level:

  • Minimum 3 years of experience

  • Education: Bachelors (required)

skills:

  • Manual QA Testing (2 years of experience is required)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information

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