Job ID: PAL001699
- 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.
- Minimal bending, lifting, and pushing