Quality Engineer

Milliken & Company is a global manufacturing leaderwhose focus on materials science delivers tomorrow's breakthroughs today. Fromindustry-leading molecules to sustainable innovations, Milliken creates products thatenhance people's lives and deliver solutions for its customers and communities. Drawing on thousands of patents and a portfolio with applications across the textile, flooring, chemical and healthcare businesses, the company harnesses a shared sense of integrity and excellence to positively impact the world for generations. Discover more about Milliken's curious minds and inspired solutions at Milliken.com and on Facebook, Instagram, LinkedIn and Twitter.

Position Summary:

Individual in this position will be part of a dynamic team with a proven track record of inventing, developing, and commercializing FDA registered medical devices. In this role the individual will interact with all functional areas of Ovik Health Products as a key representative of the quality function, in a hands-on manufacturing setting.

Key Responsibilities:

Quality Systems:

• Lead in identifying and realizing new product and/or new process introductions as well as process improvements to drive a quality first focused culture during commercialization and production of products.
• Act as the engineering expert in quality, using and teaching various tools and methods (for example, Six Sigma, Lean) to achieve improvement targets.
• Partner with key operations and quality leaders in various risk management and risk mitigation exercises and tools (for example, mistake proofing, critical control points, failure mode, and effects analysis).
• Act as a key contributor to reliability assessments in product realization.
• Partner with "floor based" quality and operations individuals to lead root cause investigations for customer complaints and nonconformances using various problem-solving techniques and assess efficacy of corrective actions.
• Support and drive the development and implementation of test methods in equipment, process, and product qualifications/validations.
• Develop Quality control plans to ensure they are in accordance with product risk level and are consistently followed.
• Implement and maintain production and process controls using appropriate techniques (for example, process capability measures, statistical process controls, and process performance metrics).
• Participates in technical reviews as appropriate.
• Review/assess current product and processes (including actions or decisions conducted) compliance to standards such as the QSRs, ISO 13485, etc.
• Other responsibilities as required.

Minimum Qualifications

• Bachelor's degree in Engineering discipline.
• 1+ year ofQuality Assurance experience
• Ability to work within a manufacturing facility
• Ability to analyze data, draw conclusion, and summarize recommendations that facilitates and drives decision making.
• Excellent verbal communication and strong technical writing skills including validation protocols/reports experience.
• Proven ability to think critically, creatively solve problems, and identify key details that others miss.
• Consistent demonstration of a "curiosity mindset" with a willingness to both learn from and teach others in a hands-on setting.
• This position requires candidates to be eligible to work in the United States without requiring sponsorship for a work visa (e.g., H-1B, TN, etc.)

Preferred Qualifications

• 1+ year of Quality Assurance experience within a manufacturing setting, preferably within a medical device manufacturing setting
• Experience in process improvement methods, such as six sigma, LEAN, etc.
• ISO Quality systems and risk management process knowledge
• Knowledge of statistical software packages and the ability to review, graph, analyze, and present data to facilitate/drive decision-making.

PERSONAL PROTECTIVE EQUIPMENT USED:

• Hairnet
• Steel Toe Safety Shoes
• Safety Glasses
• Nitrile Gloves

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Milliken is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to actual or perceived race, color, creed, religion, sex or gender (including pregnancy, childbirth or related medical condition, including but not limited to lactation), sexual orientation, gender identity or gender expression (including transgender status), ancestry, national origin, citizenship, age physical or mental disability, genetic information, marital status, veteran or military status or any other characteristic protected by applicable law.