Hatch Pros ยท 11 hours ago
Medical Device Quality Engineer
United States
Contract
Remote
Entry, Mid Level
$40/hr - $45/hr
2+ years expHatch Pros is seeking a Medical Device 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 working with cross-functional teams to ensure compliance with applicable standards.
Information Technology & Services
No H1B
Responsibilities
Facilitating risk management assessments, updating risk plans and reports, consolidation and updating 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
Assessing legacy risk documentation and identifying 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
Ability 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
Qualification
Required
Bachelor's degree or equivalent in a related technical or engineering discipline
2-3 years of experience or equivalent combination of education and experience
General knowledge of and application of principles and theories of quality engineering and risk management
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
Preferred
Understanding of Medical Device/GMP/ISO regulations (ISO 14971, ISO 13485, MDSAP and FDA CFR Part 820)
FDA CFR Part 210/211 preferred
Experience with IVDR (In Vitro Diagnostic Regulations)
SAP, EtQ and/or Veeva experience a plus
Company
Hatch Pros
At Hatch Pros, we provide a unique blend of IT solutions and staffing services to businesses all across the USA.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase