To oversee and perform receiving, in-process and final inspections of the QMS. Ability to verify manufacturing processes for conformance and product specifications in relation to all ISO 9001, FDA, USDA and associated regulatory standards. Improving the inspection systems using SPC, control charts and data collection for analysis. Implement and suggest continuous improvement ideas throughout the entire QMS to the quality manager.
Description of Essential Job Functions
• Supervise a quality team of (4-7) within a face paced, evolving, heavily regulated ISO certified company
• Supervise and oversee that all inspectors are trained to all required procedures and processes as per procedure training matrix. Lead trainer for all new quality inspectors as well as ongoing continuous training of current inspectors
• Supervises and prioritizes all incoming testing, start-up inspections and final testing of manufacturing jobs performed daily. As well as perform them as applicable to ensures they are done in compliance of procedures.
• CAPA/SCAR/MRB member (Corrective Action Preventive Action/Supplier Corrective Action/ Material Review Board), Be involved as a board member and help manage the non-conforming materials, corrective actions as well as quarantined product. Will help issue relative documents and applicable investigations as needed. Will help in the resolution and investigation of issues which occur during manufacturing or all quality related processes. Create and send comprehensive investigational reports for distribution to all departments for proper inter-departmental communication for a quick resolution.
• Will be an active participant in the internal auditing program and will be conducting audits as assigned. (Training will be provided per cGMP Internal Auditing Program)
• Will be a participant in conducting validations of newly acquired automation and or related quality components.
• Will oversee and help manage the calibration program along with monthly generated reports of the system. Manager outside contractors to schedule timely calibration item pickups or internal services which relate to this process.
• Will work intimately with Document Control department and management on generating SOP’s (standard operating procedures), work instructions, procedures and test methods for QMS related processes.
• Will oversee environmental monitoring system per cGMP requirements, this includes controlled storage monitoring at various intervals (temp data recording) and ensuring the active clean rooms (Class 7 and Class 8) are certified for compliance.
• Will be an active participant in the RGA (Returned Goods Authorization) process, including – preparing corrective action reports, cause and effect diagrams, preventive action reports for continual improvement throughout the QMS.
• Will assist in performing customer complaint investigations as well as root cause analysis and report writing. This includes working and communicating with appropriate department leaders as required per the investigation.
• Ensures compliance with and/or follows all organizational systems, programs, training, policies, and procedures as required and complies with relevant legal mandates. Seeks guidance as necessary.
• Actively supports and participates in the safety program, both for self-protection and the protection of other employees, by reading and abiding by all requirements in the Safety Manual and Injury Illness Prevention Program (IIPP).
• Carries out all responsibilities in an honest, ethical and professional manner.
• Must be able to fulfill essential job function in a consistent state of alertness and safe manner.
• Handles various other duties as delegated by Manager.
In accordance with applicable policies/procedures and Federal/State laws, may perform the following supervisory responsibilities: Interviewing, hiring orienting and training employees; planning, assigning, and directing work; coaching and appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; enforcing all safety rules and ensuring safe work procedures.
• Bachelor’s Degree in Engineering, Management, Quality, Chemistry, Microbiology or a related field required understanding of basic QMS clauses and activities required by ISO standards
• Minimum of 5 years of experience in the quality field
• Minimum of three (3) years’ experience in a supervisor or lead role
• Intermediate knowledge of Microsoft Office (Outlook, Word, Excel, Visio, PowerPoint)
• Knowledge of Microsoft Navision Dynamics MRP system is a plus
• Experience in performing internal audits, continuous improvement and MRR (Material review records/ Non-conforming material forms). Knowledge of or experience in QMS continuous improvement skills such as Six Sigma, Kaizen or Lean Manufacturing is a plus.
• Excellent verbal and written communication skills
• Must be a strong leader in a team, be self-motivated and have the ability to motivate others
• Must be able to multitask and time manage multiple projects concurrently is key
• Superb listening skills and ability to probe for better understanding of applicable situations
• Problem solving aptitude to accurately define, analyze, break down, and solve complex
problems or breakdowns in a process or the QMS.
• Must be able to delegate and manage work load within the department
• Must be able to adapt and flex to a changing environment during this time of rapid growth
• Must be able work well under pressure
• Will occasionally be required to travel.
• May occasionally work evenings and/or weekends
• Able to communicate between other department supervisors and managers as applicable
Qualified and interested candidates are urged to contact: Jackie Hoofring, President/Avalon Staffing, firstname.lastname@example.org, (805) 367-3260.