Works closely with other functions within the organization (Manufacturing, R&D, Quality, Engineering, Procurement, Marketing) and is responsible for ensuring the quality of the product and process for the assigned product line(s). Develops, modifies, applies and maintains quality standards and protocols. May be responsible for developing and implementing strategic quality plans, master validation plans, validation protocols, inspection plans and quality/regulatory compliance operating procedures to meet FDA (Food and Drug Administration) and ISO (International Organization of Standardization) requirements.
First Shift / Day Job
- Thorough knowledge of quality system regulations/requirements (i.e. ISO-International Organization for Standardization, FDA-Food and Drug Administration, GLP / GMP-Good Lab / Manufacturing Practices, QSR-Quality System Regulation
- Effective communication skills at all levels both written and verbal.
- Effective skills in analytical thinking and problem solving.
- Ability to perform multiple tasks and ability to effectively manage conflict.
- Ability to work in teams to obtain results, self motivated/directed, ability to organize and supervise people and activities, minimal supervision required.
- Knowledge of manufacturing processes and relevant statistical techniques (Six Sigma, Statistical Process Control (SPC).
- Basic to intermediate proficiency in Microsoft Office and statistical programs (i.e. MiniTab, SAS).
- Understanding of continuous improvement methodologies including lean, six sigma, and validation.
- Professional certification is preferred (i.e. CQA-Certified Quality Auditor, CQE-Certified Quality Engineer, SQE-Sofware Quality Engineer, CQM-Certified Quality Manager, etc.).
- SAP experience preferred.
- BS degree in Life Sciences, Engineering (Biology, Chemistry, Microbiology, Electrical, Mechanical, Software/