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: Quality Engineer, Salisbury, MA

Job Classification: Exempt

Position Reports to: Quality Manager

COMPANY OVERVIEW:

At OVIK Health, we develop advanced wound, skin, compression, cohesive, tapes, and burn care products with the mission to "Improve Patient Lives". We create technically advanced products designed for consistency, dependability, and ease-of-use, while maintaining the highest ethical standards. We help drive positive outcomes by providing our customers with superior quality products, dedicated support and ongoing education.

OVIK Health, a division of Milliken & Company, our work begins behind the scenes often taking shape in a lab. The molecules and materials we create are transforming lives and experiences around the world. Our associates work to create entirely new customer experiences, build for the future, and create products that do good for the world. We've been a global leader for over 159 years in researching, designing, and manufacturing specialized textile, chemical, healthcare, and flooring products. Named as one of the World's Most Ethical Companies list by Ethisphere Institute for 15 consecutive years, we rally behind a common purpose: striving to positively impact the world for generations.

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 inEngineering discipline.
• 1-2 yearsQuality Assurance experience within a manufacturing setting, preferably within a medical device manufacturing setting
• 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.
• 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.
• Excellent written and verbal communication, with the ability to communicate across all levels and departments within an organization.
• Consistent demonstration of a "curiosity mindset" with a willingness to both learn from and teach others in a hands-on setting.
• Willingness to embrace and embody the core values of Milliken.

PERSONAL PROTECTIVE EQUIPMENT USED:

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

PHYSICAL REQUIREMENTS FREQUENCY, AMOUNT, OR DESCRIPTION

1. Standing: Ability to stand while working;50% of day

2. Sitting: Ability to sit down;50% of day

3. Moving: Ability to move throughout plant;90% of day

4. Lifting: Ability tolift upto25lbs.; 15% of day

5. Ascending/Descending:Ability to walk upstairs,climb to top of range (approx. 16 ft);10% of day

6. Push/Pull/Reach: Ability to push/pull fabric rolls,A-frames (approx 1500lbs); 10% of day

7. Bending: Ability to pick up objects from the floor;25% of day

8. Visual Acuity: Visual acuity adequate to perform job duties, including reading information from printed sources and computer screens; 100% of day

9. Cognitive: Alert. Able to make decisions, reason, and understandinformation; 100% of day

WORK ENVIRONMENT/SAFETY-SENSITIVE POSITION

This job operates in a manufacturing facility. This position is a safety-sensitive position and regularly works around moving mechanical parts and powered industrial vehicles.

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.