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