Quality Engineer

• 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.

• 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), and FDA CFR Part 210/211 preferred.
• 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

SAP, EtQ and/or Veeva experience a plus.