Description
Senior Quality Engineer/Design Engineer
Senior + Quality + Engineer + Design Control + Risk Management + Design Verification + Validation + Medical Devices
Both positions are for a Senior Quality Engineer,
Ideal candidates should have an Engineering degree with experience in Design Control, Risk Management and Design Verification/Validation of medical devices.
The person should have working understanding of ISO 14971:2012 (Risk Management), ISO 13485:2012 (Medical Devices), 21 CFR 820.30 (FDA Quality System regulations - design control) and ideally ISO 15197:2013 (IVD requirements for blood glucose monitoring).
Technical Competencies & Responsibilities
Has a planning outlook out for the next year
May lead people, directing day-to-day tasks and planning for future deployment.
Coach or mentor to others in function.
Translates a given strategy into tactics and measures, independently. May participate in strategy development.
Leads complex projects within own function. Significant involvement in cross functional or global projects.
Proactive & forward thinking. Drives & implements continuous improvement activities.
Makes decisions based upon data. Understands the balance of day-to-day activities versus big picture. Can assess risk and take action appropriately. Escalates issues as appropriate.
Is recognised as a Subject Matter Expert and functional 'go-to' person for a broad area.
Design
Participates in the core team for a new product team.
Understands customer needs and works with business partners to implement improvements to product designs.
Understands principals of Human Factors engineering and Reliability Engineering
Operations
Leads support of operations for both day-to-day goals and future growth. Influences business partners & suppliers to ensure product quality and compliance to quality systems.
Identifies opportunities for, and leads activities such as: defect reduction initiatives, quality metric improvements, root cause analysis, problem solving.
Leads activities related to transfer of product design into operations.
Drives others to use Plan-Do-Check-Act and other established problem solving methods.
Quality Systems
Understands the breadth of the quality system and how it fits into the wider business perspective. Leads significant improvements to quality systems.
Trains others in quality systems, tools and objectives.
General
Leads activities within the quality system such as: change control, design control, NC, CAPA, supplier monitoring, risk management activities.
Excellent written and oral skills
Result driven
Excellent social skills
Team player
Able and willing to work in a complex organization with highly detailed rules and regulations
Computer literate