Cypress HCM ยท 4 hours ago
Quality Engineer
Hercules, CA
Contract
Onsite
Entry Level
$40/hr - $45/hr
2+ years expCypress HCM is a global, industry-leading company seeking a Quality Engineer to facilitate the updating and consolidation of legacy product risk management files related to IVDR. The role involves coordinating risk management assessments, supporting product risk management file migration, and ensuring compliance with established procedures and standards.
Human ResourcesInformation TechnologyStaffing Agency
Responsibilities
Facilitate risk management assessments, update risk plans and reports, consolidate and update product system hazard analysis files in accordance with established company procedures and applicable standards
Coordinate and facilitate meetings with cross functional stakeholders as needed to obtain information and data needed for completeness and accuracy of risk profiles for existing hazards, and identification of new risks and hazards as needed
Escalate events to Management that require additional inputs or mitigations
Support product risk management file migration into the eQMS system including ensuring document meta data is accurate and files are accurately linked to legacy product DHF binders in coordination with DHF migration efforts
Assess legacy risk documentation and identify gaps against initial IVDR transitional activities versus new guidance documents and updates to global risk management procedures
Support other IVDR related technical documentation updates and gap assessments as required, including migration into eQMS as needed
Qualification
Required
Bachelor's degree or equivalent in a related technical or engineering discipline
2-3 years experience or equivalent combination of education and experience
General knowledge of and application of principles and theories of quality engineering and risk management
Understanding of Medical Device/GMP/ISO regulations (ISO 14971, ISO 13485, MDSAP and FDA CFR Part 820)
General understanding of risk management regulations, principles, and application
Excellent critical thinking, problem solving, coordination, teamwork, communication, technical and computer skills
Proficient in Microsoft Office, Visio
Able to work in an ever-shifting environment and possess a high level of patience to support cross-functional teams with shifting priorities
A self-starter who can work independently and possesses a sense of ownership and accountability to the activities assigned to them
Preferred
FDA CFR Part 210/211 preferred
SAP, EtQ and/or Veeva experience a plus
Company
Cypress HCM
Cypress HCM is a staffing and recruiting company providing technology and creative recruiting solutions.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Mark Lillig
CEO
Philip Oommen
CFO
Company data provided by crunchbase