Supplier Quality Engineer

• An ability to develop and implement quality control plans, including defining acceptance criteria and inspection procedures for incoming materials.

• Data-driven decision making to support business cases.

• Superior Excel, Minitab, Statistics skill (pivot tables, slicers, charts, formulas, graphical & data analytics, large dataset management, etc.)

• Self-Driven initiative to identify, prioritize, and execute high-impact quality initiatives that contribute to the top/bottom line.

• Excellent organizational and time management skills.

• Excellent interpersonal and communication skills (both verbal and written) that allow for effective communication with all levels of the organization

• Ability to present data effectively

• Demonstrated ability to collaborate with cross-functional departments and stakeholders in a proactive and constructive manner

• Manufacturing or production environment experience

• Experience with quality management systems like ISO 9001, ISO 13485, and proficiency in quality tools such as SPC, FMEA, and 8D.

• Ability to travel 25-50%

• Takes initiative and ownership to drive department and organization goals

• Experience with ISO 13485 - Medical Devices Quality Management System (QMS), ISO 13485 Change Control Program, and ISO 13485 CAPA Program

• Experience with ISO 11607 (Packaging for terminally sterilized medical devices)

• Experience with ISO 14971 (Application of risk management to medical devices)

• Experience with 8D, Root Cause Analysis, Corrective Action

• Six-Sigma Green Belt / Black Belt

• Bilingual in English and Spanish

• Conduct regular on-site audits and evaluations of vendor facilities to assess their manufacturing capabilities, quality systems, and compliance with industry standards like ISO 9001, or ISO 13485.

• Lead/Conduct Root Cause Analysis (RCA) and implement Corrective and Preventive Actions (CAPA) for defective parts or manufacturing yield issues.

• Track supplier performance using Key Performance Indicators (KPIs), metrics, and scorecards to drive continuous improvement.

• Support design and engineering teams in selecting and qualifying new suppliers and parts.

• Facilitate communication between internal departments (procurement, engineering, production) and suppliers to resolve technical and quality discrepancies.

• Oversee First Article Inspection processes and review inspection plans, ensuring CTQs are called out.

• Identify improvement opportunities, work with suppliers on process enhancement, and reduce the overall cost of poor quality.

• Maintain supplier scorecard, create performance reports, and ensure compliance with QMS/Regulatory requirements.

• Evaluate new suppliers to ensure they have the necessary manufacturing and technology capabilities.

• Conduct internal audits, as needed, and support external regulatory body audits.

• Facilitate the escalation of unresolved supplier quality issues.

• Analyze quality data and metrics to identify trends and areas for improvement.

Printpack is proudly an equal-opportunity employer. We are committed to creating an inclusive environment. Embracing diversity enhances our work culture and is vital to our success. We do not discriminate based on race, color, religion, sex (including pregnancy), national origin, gender identity, sexual orientation, marital/parental status, genetic information, age, national origin, ancestry, ethnicity, disability, marital status, military or veteran status or affiliation, or any other characteristic protected under applicable law.

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Know Your Rights - Conozca sus Derechos - Your Rights Under USERRA (dol.gov) - FMLA - FMLA (Spanish) -Polygraph Protection - Right to Work - Right to Work (Spanish)

Printpack is committed to helping individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs. If you need a reasonable accommodation to assist you with your application for employment or job search, please get in touch with us by sending an email to CorpRecruiting@Printpack.com. Please include in your email a brief description of the accommodation you are requesting and the position for which you are interested in applying.