Quality Manager

• Provide subject matter expertise and accountability for Quality Risk Management (QRM) Program
• Provide QRM (ICH Q9 and ISO-14971) guidance and support to various cross-functional organizations.
• Facilitate risk analysis (FMEA, FMECA, PHA, HACCP and other equivalent accepted methods).
• Analyzes data from various sources (including, but not limited to: Non-Conformances, CAPAs, Deviations, Complaints, etc.) to identify and initiate QRM opportunities.
• Escalate critical risks identified during risk assessments to management.
• Perform Risk Analysis activities to ensure process and product shortcomings are identified and appropriately addressed (10 - 15%)
• Educate and train appropriate personnel on quality risk management practices and associated risk documentation requirements (10 - 15%).
• Maintain Risk Register process
• Coordinate the input process for new risks added into the Risk Register.
• Create periodic (monthly) management reports highlighting critical risk register events.
• Verify activity status of risk register events for closure with appropriate risk action owners.
• Escalate critical risk events to Management (immediate supervisor and others) (5 - 10%)
• Create Quality Risk Management standard operating procedures, such as; FMEA, PHA, HACCP, PHA, etc. as required (5%).
• Participate in regulatory agency inspections for Quality Risk Management initiatives.
• Author and review responses to inspection observations and agency questions pertaining to QRM (5%).
• Identify opportunities for continuous improvements and enhancement of QRM program to reflect current regulations and industry trends.
• Writing/Editing SOP’s
• Facilitate risk training sessions
• Facilitating SOP for Risk Assessment
• Finding someone to do Risk Assessment/Or doing risk assessment themselves
• Supporting regulatory inspections
• Assisting with work overflow with risk register activities
• BS/MS in science related field or an engineering degree with having 6-8 years of Quality within risk methodology experience OR at least a member of the risk assessment team

MUST HAVE

FMEA

Nice to have

HACCP/ PHA experience

Regards,

Ricky

732-429-1925