Quality Assurance Engineer

Position Overview 

The Quality Engineer position establishes and maintains quality standards to reflect efficiency, reliability, and performance within the Quality team. The Quality Engineer will monitor and improve the quality of IVC’s operational processes as it relates to Manufacturing Operations, Supplier Quality Management, New Product Development (QbD), and Product Site Transfer projects. A successful Quality Engineer should have excellent quality, operational, and technical experience. The successful Quality Engineer will also have project management and troubleshooting skills and be able to support processes and products so that they consistently meet established quality standards. 

Specific Responsibilities  

• Lead investigation and root cause analysis for manufacturing deviation and errors, provide final report for review & approval and track the timely investigation completion. 

• Reviewing and communicating designated Quality metrics and CAPA project status and effectiveness verification summary to Sr Quality leadership. 

• Lead Quality by Design (QbD) initiatives. Partner with Quality Operations, R&D and Operations to identify critical quality attributed (CQA), define desire product performance profile, and ensure product formulation and manufacturing process designs meet quality, performance, reliability, and affordability goals. 

• Work with Quality Operations, R&D and Operations to assess, manage and control critical material attributes (CMA), critical process parameters (CPP) and critical variances that may impact the CQAs  

• Support Corporate Innovation projects including technical assessment of new products and/or new manufacturing initiatives (i.e. gummies/powder/liquids etc.). 

• Lead QTS Data Summary, Assessment and Statistical Analysis 

• Manage supplier quality performance reviews, contract supplier specifications and approvals, and enhance robust Life Cycle Management (LCM) processes for IVC’s supplier base with partner groups. 

• Assist Quality Technical Services Leadership on special project duties as assigned. 

General Responsibilities 

• Poses no direct threat to the health or safety of himself/herself, of others, or to property. Defined as a significant risk of substantial harm that cannot be eliminated or reduced to an acceptable level by reasonable accommodation.    

• Requires regular attendance to perform essential element as contained herein between the assigned start and end times for work.   

• Performs such individual assignments as management may direct.    

• Other duties as assigned.   

Education, Experience, and Licenses: 

• Bachelor’s degree in related field 

• Minimum of 6 years of experience in related field 

• Experience using Lean/6-Sigma type problem solving tools (i.e. RCA, 5-whys, DMAIC, etc)  

• Experience working within MRP/ERP systems, preferably Oracle-based systems   

Knowledge, Skills, and Abilities 

• Strong working knowledge of FDA 21 CFR 111, 110, 117, ISO 9001, and ISO 9000 requirements is required. 

• Excellent oral and written communication skills and ability to communicate effectively with all levels of the organization. Foreign language communication skills preferred 

• Effective analytical and problem-solving skills. Excellent attention to detail, resourcefulness, self-reliance, and confidence. 

• Good project management skills and good working skills with Microsoft Office Suite applications are required. 

• Statistical process control knowledge and experiences desirable 

• CQE and/or CQM and/or CQA professional certification desirable. 

• Ability to function effectively at both strategic and tactical levels with minimum supervision. Highly motivated and team oriented and ability to multi-task 

International Vitamin Corporation (IVC) Is an Equal Opportunity Employer. Our organization remains steadfast in our commitment to fostering an inclusive and non-discriminatory work environment that welcomes individuals from all backgrounds. We firmly maintain the belief that every individual ought to be treated with respect and dignity, regardless of their race, color, religion, sex, sexual orientation, gender identity or expression, age, national origin, disability, veteran status, marital status, genetic information, or any other protected characteristic, as defined by the law. We pledge that all eligible job applicants shall receive an impartial and unbiased evaluation during the recruitment process, without any form of discrimination based on any of the protected class. Our dedication to promoting diversity and inclusivity remains unwavering, and we take immense pride in cultivating a workplace culture that values and celebrates differences. Our efforts towards creating an environment that is free from prejudice and discrimination are an integral part of our organizational philosophy, and we stand committed to upholding these principles.