SENIOR PROJECT ENGINEER, QUALITY PACKAGING ENGINEERING - Abbott Laboratories / Columbus, OH
Support ongoing supplier management process to assure high-quality supplies of packaging materials through evaluation and development of company suppliers worldwide as a member of the Global Supplier Quality Assurance (GSQA) group. Perform supplier qualification assessments of new packaging suppliers to ensure the quality design of the package and the supplier’s processes, facilities, and systems meet company and regulatory requirements. Develop packaging suppliers’ systems and processes to improve process capability, assure supplier in-line equipment is validated, and develop certificates of analysis pursuant to Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) validation programs. Collaborate with Packaging Development to develop, validate and issue packaging methodology and equipment pursuant to process and equipment validation programs. Conduct equipment Repeatability & Reproducibility (R&R) studies by conducting statistical analyses, performing quality and compliance audits, and evaluating system compliance pursuant to Quality System Regulations 21 CFR 820 and ISO:13485 at qualification to assure that testing between plant and suppliers is aligned and validated. Conduct reviews and updates to supplier regulatory documentation that is submitted with all packaging changes and new qualifications to assure regulatory compliance with 21 CFR 820 and ISO:13485. Maintain and control the approved supplier status of suppliers. Maintain documentation such as Supplier Quality Management (SQA) policies, procedures, specifications, and acceptance programs utilizing experience with quality systems and quality processes like Lean Six Sigma (DMAIC Process). Assure the proposed changes made to supplier processes are approved and compliant to specifications. Provide support to global operations by resolving packaging material issues and work with plants to develop sampling and correction plans. Manage packaging material issues and work with plants to develop sampling and correction plans. Manage packaging supplier recurring Corrective Action/Preventative Action (CAPAs) on a monthly, quarterly and annual basis by evaluating exception report data and reporting information to appropriate areas of the business (i.e. Purchasing and Operations) and suppliers. Support resolution of packaging material issues and approval of exception reports within plants. Lead investigations and perform root cause analyses to resolve and troubleshoot supplier processing or packaging issues. Monitor packaging complaints monthly and quarterly and identify and resolve trends within packaging categories. Up to 25% travel required.
Master’s or foreign equivalent degree in Mechanical Engineering, Industrial Engineering or in a related field (alternatively, will accept a Bachelor’s or foreign equivalent degree in a related field and 5 years of progressive work experience in Quality Engineering roles in lieu of a Master’s degree) each alternative requirement with at least 1 year of experience in: (i) validation programs including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ); (ii) conducting statistical analyses and performing quality and compliance audits pursuant to Quality System Regulations 21 CFR 820 and ISO:13485; (iii) utilizing experience with quality systems and quality processes like Lean Six Sigma (DMAIC Process); (iv) performing root cause analysis and supporting CAPA process; and (v) up to 25% travel required. Employer will accept any suitable combination of education, training, or work experience.
Respond by mail: Abbott Laboratories, Kathleen Ellwanger, 100 Abbott Park Rd, Dept 32RC, Bldg AP6A, Abbott Park, IL 60064-3500. Refer to Ad Code: ABT-00592-KE.