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W. L. Gore & Associates · 1 day ago

Quality Engineer

Flagstaff, AZ

Full-time

Onsite

Mid Level

3+ years exp

W. L. Gore & Associates is seeking a talented Laboratory Quality Engineer to join their dynamic team. The role focuses on enhancing laboratory operations by maintaining and optimizing analytical test methods, collaborating with cross-functional teams, and driving quality improvement initiatives.

Health CareManufacturingMedical Device

No H1B

Responsibilities

Optimize and maintain analytical test methods to ensure laboratory adherence to safety, regulatory compliance, and efficiency standards

Update and maintain risk documentation through continuous evaluation of current data to support effective operations

Apply statistical techniques to enable data-driven decision making in daily operations and continuous improvement endeavors

Collaborate with cross functional teams to conduct thorough root cause analyses for in-process rejections and data trends

Build comprehensive technical expertise in laboratory test methods and equipment validations to support audits, change control, and pFMEAs

Document and communicate technical plans, experimental results, and conclusions of work to satisfy quality system requirements and enable future use of knowledge

Lead or support quality investigations related to NCRs, CAPAs, and LQEs to maintain laboratory operations

Support material qualification and validation planning, as well as drive and support equipment, software, and method validation processes

Identify, lead, and support continuous improvement projects to drive excellence in lab functions

Routinely evaluate critical quality processing factors (environmental conditions, process inputs, process control equipment, etc.) to mitigate risk of impact on operations

Qualification

Analytical test methodsStatistical analysisQuality system documentationRegulatory complianceLean Six SigmaProject managementCollaborationProblem-solvingCommunication

Required

Bachelor's degree in Engineering with a minimum of 3 years of engineering work experience

Experienced in reviewing, approving, and managing documentation in a quality system (e.g., SOPs, protocols, reports, and WPs)

Demonstrated compliance to regulatory requirements (e.g., governing quality systems, product safety, and cGxP)

Ability to prioritize, plan, and drive multiple projects concurrently from development to completion in accordance with agreed upon timelines and deliverables

Ability to apply engineering fundamentals and statistical analysis to drive/support product quality, trending, improvement, and troubleshooting; ability to support external and internal audits

Demonstrated ability to identify, analyze, and resolve complex quality issues by applying structured problem-solving methodologies and risk analysis tools

Ability to foster and maintain strong collaborative working relationships on team and cross functionally (Engineering, Manufacturing, R&D, QA, QCU, QC, Product Specialist, IT)

Ability to make effective risk-based decisions, including the use of pFMEAs

Ability to effectively document, communicate, and present technical bodies of work to a diverse group of Associates

Ability to work in a dynamic, fast paced laboratory setting where experimental inputs and expected outcomes may be uncertain or evolving and to travel up to 5%

Preferred

Experience in Project Management and utilizing structured PM tools/methodologies such as MS Project, WBS establishment, and Critical Path identification

Demonstrated application of lean Six Sigma methodologies such as statistical process control (SPC), pareto charts, and failure analysis

Familiarity with standards and regulations relevant to combination products, such as FDA 21 CFR Part 4, ISO 13485 guidelines