Planning, developing, and implementing ISO and cGMP compliance elements to enhance the Quality Management System
Project management to execute implementation plans, and drive quality objectives and goals.
Customer Audits and resolving customer complaints.
Essential Job Functions:
Manage customer complaints, nonconforming product, root cause investigation, corrective/preventive actions, audits, document control, and training daily
Assist with investigation of internal and external non-conforming product, materials, and components daily
Oversee the internal audit function to ensure ongoing compliance to the Quality Management System monthly
Perform necessary functions to verify corrective action effectiveness on manufacturing processes and support functions monthly
Develop and deliver quality training for manufacturing and support function personnel based on working knowledge of ISO, CFRs, and SOPs quarterly
Review/approve change control activities, non-conformances, customer complaint investigations daily
Manage external customer assessments from scheduling to audit close outs monthly
Responsible for measurement and analysis of Quality System trends monthly
Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws
Perform other duties as assigned
Bachelor’s degree in Science in Engineering, Biology (or science related), or Math
5-7years’ experience in cGMP or ISO quality system manufacturing environment
2-4years’ supervisory experience (preferred)
Uses and interprets statistical data for making business decisions
Ability to explain, describe, or share information clearly; Organizes information in a framework others can understand.
Expert ability to produce effective, concise written communications about technical subjects including engineering studies, qualification protocols, and technical reports. Reviews written material and recommends revisions.
Ability to work on multiple projects, managing a broad range of tasks and prioritizing activities
Strong team-building skills; Acts to promote commitment to a team task or goal
Ability to influence peers and managers to ensure that objectives are met on time
Performs on-the-job training using tools, equipment, and materials trainees will use
Demonstrated ability to effectively manage multiple moderately complex projects simultaneously.
Must demonstrate and project integrity to employees and customers and uphold the company’s highest ethical standards
Effective interpersonal skills at any level within the organization
Lead and offer opinions and direction to colleagues
Ability to interact effectively with internal and external customers in order to accomplish goals
Knowledge in Regulatory, Compliance Systems and Standards
Knowledge of ISO, FDA, cGMP’s, and CFR requirements
Experience with Root Cause Analysis Tools, Lean Manufacturing, and Six Sigma.
Knowledge of Kepner Tregoe, SPC, and quality statistical methods and tools (preferred)
Experience in Kaizen events
Understanding and experience in the application of FMECA and DOE
Proficient computer skills in handling spreadsheets, presentations, and new systems
Ability to manage budgets
Applicable safety trainings such as: RCRA, DOT, etc.