Location: Old Fort,OH, USA
A collective energy and ambition. A place where you can make a real difference.
We're a company that genuinely cares about our people, our products, our consumers and the environment.
Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries.
United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win.
Position Overview
The Quality Engineer will lead the continual improvement program, oversee process validations and host customer audits, in addition to ensuring the plant maintains compliance to FDA Regulations, Global Food Safety Initiative (GFSI) Standards and customer requirements. This position will coordinate GFSI activities, ISO 9001:2008 certification and Quality Management System between Old Fort and Green River Plants.
* Lead the Plant Continual Improvement/ Executional Excellence Programs using capability studies for products/processes improvements and Lean Six Sigma processes for plant cost savings/efficiency gains.
* Ensure Quality Systems complies with requirements outlined in the C&D Global Quality Manual, ISO 9001:2008, Global Food Safety Initiative Standards, and FDA cGMP regulations.
* Oversee the internal audit program monitoring plant quality systems to support the plant audit ready goal.
* Conducts and leads quality and customer complaint investigations.
* Host Customer audits, provide audit responses and ensure completion of follow-up corrective actions for all identified non-conformances.
* Apply Quality Engineer skills to oversee the plant validation program, to perform Statistical Process Control (SPC) tests for line capability understanding and monitoring, and to provide plant-relevant input into FMEA's, lessons learned and DfM analyses.
* Lead Quality and CAPA Investigations by assisting in trouble shooting of non-conformance findings and complaints, assisting/facilitating root cause analysis and problem-solving.
* Interact with Corporate Brand Teams and R&D Groups on new products and product improvements, coordinating R&D test trials to design appropriate tests and scale-up trials.
* Execute Corporate Quality Initiatives in the plant, including responsibility for implementing the Technology Transfer Process as well as providing input to the process during R&D product/process development.
Qualifications:
Education and Experience:
* BS/MS degree in related field required (Quality Engineering certification desirable)
* Minimum of 5 years quality experience in the consumer products, medical device, and/or pharmaceutical industries.
* Knowledge of cGMPs, 21 CFR Part 110, 210/211 or Global Food Safety Initiative Standards, and HACCP
* Experience working in a plant environment
Special Skills and Competencies:
* Knowledge of Quality Engineering, auditing of manufacturing operations for medical devices, OTC drug and /or food industries.
* Lean Six Sigma Green Belt preferred; Black Belt a plus
* High initiative with demonstrated leadership, results achievement and orientation.
* Excellent influence, persuasion, verbal and written communication skills required.
* Trained auditor in GMP, and ISO 9001 or ISO 13485 a plus
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Church & Dwight is proud to be an Equal Opportunity Employer/Veterans/Individuals with Disabilities.
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