Senior FDA Software V&V Quality Engineer
Kforce Inc

Carlsbad, California

Posted in Recruitment Consultancy
about 1 month ago


This job has expired.

Job Info


RESPONSIBILITIES:

Kforce is seeking a Senior FDA Software V&V Quality Engineer in Carlsbad, CA.Summary:The Senior FDA Software V&V Quality Engineer requires previous FDA, V&V experience and supports Quality Assurance, R&D, and Manufacturing Engineering, and Operations in the design and manufacture of electronic medical equipment, in compliance with applicable regulatory and statutory requirements, including but not limited to 21 CFR 820 (Quality System Requirements), EN ISO 13485:2016, EN ISO 14971:2012, and CGMP.Responsibilities:
  • Performs and/or reviews product software acceptance testing; Reviews and approves test results; Creates, reviews, and approves test data and test reports
  • Represents Software V&V Quality Assurance during the Design Control and Design Review process through review and approval of the applicable Design Input, Design Output, Design Verification, Validation, and Design Transfer
  • Assists with the definition and deployment of downstream processes, such as field service procedures, issue investigation, and investigation of product returns
  • Supports all company internal and external audit functions and coordinate activities of third-party audits
  • Supports activities related to Management Review, CAPA, Nonconforming materials, Process Deviations, Complaints, Product Field Actions, internal and external audits, and related document control functions
  • Works independently, but contribution's impact the overall team's objectives; Influences some of the overall project goals. Is a collaborative team player and demonstrates open-mindedness and flexibility
  • By way of example, sets a precedent for being a positive team member; Is a resource for cross-functional informational sharing
  • Responsible for compliance with quality system procedures and all regulatory requirements
  • Participates in onsite manufacturing or onsite repair of electronic medical equipment used for diagnostic or treatment purposes


REQUIREMENTS:

  • Typically requires a minimum of 7 years of related experience and a Bachelor's and/or Master's degree in a scientific/engineering discipline; Or equivalent combination of education and experience
  • 2-5 years of experience in complex electronic software medical devices working within Quality is required
  • Applied understanding of 21 CFR 820, EN ISO 13485:2016, ISO 14971:2012, and EN 62304:2015
  • Demonstrated experience in Design Controls and Risk Analysis
  • Demonstrated expertise in Process Validation, Product Validation, and Statistical Methods
  • Consistently demonstrates technical proficiency and developing innovative solutions; Anticipates and provides solutions for obstacles and challenges; Regularly collaborates with others in suggesting valuable solutions; Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors; Exercises judgment within broadly defined practices in selecting methods, techniques and criteria for obtaining results; Collaborates cross-functionally, may lead a team or project
Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.


This job has expired.

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