À propos
This position interacts with a wide spectrum of people both internal and external to the organization to resolve quality and process related issues of manufactured and supplier products along with implementing continuous improvement to the product quality, the quality system, and the manufacturing process. The Quality Engineer will provide guidance and support to the Nonconformance process to facilitate timely and effective NCR (Nonconformance Report) investigations. The Quality Engineer will also support qualification and validation activities performed by the Engineering department. Reports To: Quality Assurance Manager Job Responsibilities: Drive continuous improvement of the quality system. Propose process improvements to strengthen systems (both Quality and Manufacturing). Provide support in the implementation of QA initiatives. Revise, review, generate, and monitor SOP's, based on documented audits, informal daily observations, NCR findings, and guidance from quality assurance manager. Conduct trainings as needed for quality and manufacturing staff. Work with Nonconformance Coordinators as an SME on internal and external non-conformances and perform root cause analysis utilizing proven tools to resolve quality, process, and product issues. Support equipment qualifications and process validations conducted by the Engineering department through collaboration, documentation review and approval (as authorized), and protocol execution (as needed). Determine quality improvement parameters by identifying statistical methods relevant to the improvement of facility manufacturing processes. Lead out as a member of the Food Defense and Food Safety Teams at the manufacturing buildings and fulfillment center (as applicable) by helping facilitate team meetings and monitoring activities in each facility and their impact on current plans. Involved in and is part of the FDA, ISO, TGA, KFDA, etc. audit response team. Comply with FDA, cGMP, and other requirements and enforcing adherence to requirements. Job Qualifications: B.S. in food science or equivalent degree; ASQC certifications highly desirable. PCQI credentialled (is PCQI) or will become PCQI within 60 days of hire. Engineering education or process engineering experience a plus but not required. A minimum of 3-5 years' experience in a quality position; Experience in food and/or pharmaceutical experience required; additional experience in dietary supplement quality assurance strongly preferred. Knowledgeable in planning, conducting various types of audits and inspections (laboratory, manufacturing, sampling plans/methods, system/documentation, etc.) Strong knowledge of cGMP's, HACCP and Food Safety with strong practical understanding and implementation of HACCP with formalized training. Knowledge of microbiology, environmental monitoring, pest control and plant hygiene processes and procedures. Possess the ability to motivate and coordinate various quality and process system related activities. Possess excellent analytical and interpersonal, verbal, and written skills. Individual must be self-motivated, creative, and assertive. Must be able to resolve conflicts effectively and efficiently. Knowledge of business analysis and computer tools: Microsoft Word, Excel, and PowerPoint. doTERRA International, LLC. is committed to employing a diverse workforce. Qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, gender expression, protected veteran status, or disability.
Compétences linguistiques
- English
Avis aux utilisateurs
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