Quality Manager

Quality Manager

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

• 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

Qualifications

• 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