About the Role

We are looking for an experienced Quality Engineer to join our Reliable Supply team supporting films made for Medical and PharmBio.  This individual will have also demonstrated their skill in applying critical thinking to solve technical challenges and successfully navigating ambiguity to breakdown problems to identify and define solutions.  In this role, your daily activities may include interfacing with internal and external partners, evaluating fitness-for-use of materials, designs, processes, tests, and products. You will be crucial in ensuring the quality of our existing products as well as next-generation new products during design and development.

As an experienced Quality Engineer, your daily activities may include manufacturing process improvement and modification, expansion of process capabilities, and further enhancement of material technology, while ensuring a safe and cost-effective work environment. You will also have opportunities to contribute to the installation, operation, maintenance, and upgrade of production and testing equipment, equipment layout, and workflow.

This position will be located at our facility in Elkton, Maryland, with the possibility of a hybrid work arrangement.

Pay and Benefits:

• $92,000 - $142,000 per year
• Factors considered in extending an offer within this pay range include (but not limited to) education, experience, knowledge, skills, and abilities.
• Medical, Dental and Vision benefits effective on Day 1 of employment! We offer a comprehensive total rewards package, including competitive benefits.  More details are available at www.gore.com/careers/benefits

Responsibilities

• Assure product quality across the supply chain by evaluating non-conforming material, identifying and resolving quality issues, and implementing process/product changes
• Partner cross-functionally, both internally and externally, to understand fitness-for-use requirements and drive the specification development of new and derivative products
• Evaluate, select, and validate components and materials from various potential supply sources 
• Champion risk-based decision making based on deep technical and historical knowledge
• Identify and monitor key product performance measures and drive improvement
• Develop test methods and fixtures to evaluate components, product designs, and materials 
• Validate test methods and products, and develop visual standards and sampling plans
• Embed statistical techniques in execution of all phases of experimentation
• Document work via reports, technology notebooks, and a quality system
• Gain an understanding of product processing and manufacturing

Required Qualifications

• Bachelor of Science degree in Engineering with a minimum of 3 years of hands-on engineering experience in a manufacturing environment post-graduation with demonstrated experienced applying engineering fundamentals
• Experience with designing and implementing methods for process control, process improvement, testing and inspection (for example - design of experiments (DOE), validation (IQ/OQ/POQ/PQ), & SPC/SQC)
• Ability to make data-based decisions (for example, use of statistical analysis)
• Demonstrated ability to leverage critical thinking to identify critical issues and failure modes, creating a framework of action to address these issues and assess root cause and improve product performance
• Ability to maked risk-based decisions (for example, use of tools such as FMEA, FTA, contingency planning)
• Ability to build depth in product knowledge across the supply chain in order to develop or improve product specifications
• Demonstrated ability to document, communicate, and present technical bodies of work
• Demonstrated ability to prioritize, plan, and champion multiple projects concurrently from development to completion against agreed upon timelines and deliverables
• Demonstrated ability to effectively interact and influence cross-functional teams, as well as work independently
• Ability to travel up to 5%

Desired Qualifications

• General understanding of quality systems, documentation, and methodologies (for example, GMP, ISO 9001, APQP, House of Quality, etc.)
• Experience applying statistical analysis to trending, improvements, and troubleshooting
• Experience building depth in product knowledge across the supply chain in order to develop or improve product specifications

This position offers a hybrid work arrangement in the country from which the Associate is employed. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore’s work arrangement policies.

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