Design Quality Engineer

  • location: Palo Alto, CA
  • type: Contract
  • salary: $105 - $115 per hour

job description

Design Quality Engineer

job summary:
he role: Software Validation Lead Consultant- Palo Alto

Role Description:

Manage the Computer System Validation (CSV) program including keeping inventory on all tools / systems requiring validation and ensure validations are maintained. Developing validation plans / protocols and executing testing for tools directly related to the QMS - Quality Management System. Working with product teams in planning and executing CSV's for project specific tools / systems. Presenting our CSV documentation to external auditors (SME for program) Manage and provide consultation on CSV of the medical device software (SaMD) supporting tools/platform/software, Quality Management Systems and Clinical Data Management software in compliance with company policies and industry standards. Ensure that software validation packages are inspection ready and in compliance with applicable company policies and procedures Work autonomously with related Product Manager/System Manager, IT contacts, and business process SMEs for this purpose Support, as SQA, the testing and implementation of software and regulated IT applications Participate in the change control process Collaborate with the development team to build compliance capabilities in order to assure the quality of the deliverables and ensure that business needs are met

Responsibilities:

  • Participate in the change control process
  • Collaborate with the development team to build compliance capabilities in order to assure the quality of the deliverables and ensure that business needs are met
  • Good implementation knowledge on 21 CFR Part 11 Compliance, Data Privacy Software controls - HIPAA/GDPR
  • Good Knowledge on drafting Requirement Specification, Design/Configuration Specification, Code reviews, Design review, Validation Plan, Risk Assessment, Validation protocol execution, Validation report,, Part 11 assessment, 21 CFR 820 applicability assessment
Top 3 Responsibilities:

Manage the CSV program including keeping inventory on all tools / systems requiring validation and ensure validations are maintained. Developing validation plans / protocols and executing testing for tools directly related to the QMS. Working with product teams in planning and executing CSV's for project specific tools / systems.

Skill/Experience/Education

  • Mandatory - 8+ years of experience in managing computerized system validation projects in a Medical Device company. - Experience with common document creation / editing tools such as Word, Excel, Acrobat, Powerpoint, Docs, Sheets, and Slides -Good implementation knowledge on 21 CFR Part 11 Compliance, Data Privacy Software controls - HIPAA/GDPR -Good Knowledge on drafting. Requirement Specification, Design/Configuration Specification, Code reviews, Design review, Validation Plan, Risk Assessment, Validation protocol execution, Validation report,, Part 11 assessment, 21 CFR 820 applicability assessment - Excellent interpersonal skills working across multiple divisions and sites and external resources. - strong customer service orientation and corresponding skills. - Excellent written and verbal communication skills. Knowledge on AAMI/ISO TIR80002-2:2017 and TIR36:2007-
  • Desired Bachelor's or Master's Degree. 2+ years of additional general Quality Assurance experience in SaMD (Software as a Medical Device).
 
location: Palo Alto, California
job type: Contract
salary: $105 - 115 per hour
work hours: 8am to 5pm
education: Bachelors
 
responsibilities:
Manage the Computer System Validation (CSV) program including keeping inventory on all tools / systems requiring validation and ensure validations are maintained. Developing validation plans / protocols and executing testing for tools directly related to the QMS - Quality Management System. Working with product teams in planning and executing CSV's for project specific tools / systems. Presenting our CSV documentation to external auditors (SME for program)

 
qualifications:
  • Experience level: Experienced
  • Education: Bachelors
 
skills:
  • Quality

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.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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