Senior Quality Engineer
As our Senior Quality Engineer, your Principle Accountabilities will involve:
• Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
• Ensure design changes to existing products are conducted in compliance with the FDA Quality System Regulations Design phases.
• Participate on cross-functional teams to review marketing requirements and to develop concise, unambiguous, con-conflicting and feasible product requirements that support the market needs.
• Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report). Create a risk management plan, perform product risk assessment, facilitate the failure mode effects analysis, and create a final risk management report
• Assist in the creation of verification and validation test plans. Oversee testing and analysis for standards and product requirements compliance.
• Provide guidance and direction for sample size and statistical analysis of verification and validation test results. Experience Statistics stools experience an advantage e.g. Minitab.
• Provide training to project teams on procedures, verification, validation, statistical methods and design controls.
• Review Design History Files and Technical Files for conformance to applicable requirements.
• Assist, when appropriate with internal and supplier audits.
As our Senior Quality Engineer your Skills & Qualifications will include:
Minimum requirements:
• BEng/BSc Level 8 degree qualified with at least 5-7 years’ experience in a manufacturing organization
• Strong familiarity with regulatory requirements (e.g. ISO 13485,CFR 820 & EN ISO 14971)
• Experience in risk evaluation techniques, e.g. HHE/HHA, Product Risk Assessment, SFMEA/HHA, DFMEA, PFMEA & fault tree analysis.
• Risk Management, ISO 14971, FTA, FMEA, HACCP.
• Familiarity with Hardware ME Design & Development: Stack Up and Tolerance Analysis, Key Inspections Analysis Material Analysis, Design of Experiments & Reliability Analysis.
Preferred requirements:
• Medical Device/Healthcare Industry experience is desirable
• Familiarity with EN ISO 60601-1, EN ISO 60601-1-8, EN ISO 80601-2-12 a distinct advantage.
• Comparative Statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing and ANOVA.
• Test plan development and root cause failure analysis.
• Previous Quality Auditor experience is desirable or certification is an advantage
• Experience in Design Quality is desirable.
Other Skills:
• Ability to work well as part of team and also to lead a team
• Strong communication, organizational and project planning skills.
• Ability to write engineering documents, test protocols, FMEAs
• DFSS / Lean Green Belt or Black Belt Able to analyze and chart data using MS Excel or Minitab
• Familiar with IEC 60601 and product specific industry standards.
• Familiar with DMAIC or DMADV(DFSS) methodologies
• ASQ CQE, CQA, CSQE and/or CRE certification.
• Familiar with statistical software tools (Minitab, Stat Graphics, Statistic),
• Stability, Biocompatibility, Sterilization, Ship Testing, HALT/HASS