Summary: Develops, establishes and maintains Quality Engineering methodologies, systems, and practices that meet Innovize customer requirements. Provides focused Quality Engineering support of manufacturing and test process development for new products to ensure the delivery of the highest quality product to the customer. This position develops and maintains current knowledge of applicable U.S. and international regulations, standards and guidance and ensures that products are manufactured in compliance those requirements and customer expectations. This position will drive successful development, deployment and maintenance of business processes, tools and training.
Works within the Operations Team to identify and implement effective controls to support the development, qualification, and manufacturability of products to meet or exceed internal and external requirements.
Lead in the testing and validation of new customer product designs to meet or exceed internal and external requirements.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
Maintain a thorough understanding of regulations and guidelines (FDA, ISO, MDD etc). Assesses effectiveness of systems with respect to all relevant regulations and requirements.
Prepare regulatory plans and compliance requirements including risk analysis. Provide on-going support to project teams for regulatory issues and questions. Find, interpret and apply regulations and guidance appropriately for situations.
Create and maintain Regulatory Affairs product files to support compliance with regulatory requirements.
Notify management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
Minimum 8 years experience in a medical manufacturing quality environment.
4 year Bachelor’s Degree, Quality Engineering certification preferred
Direct experience in a Quality role supporting operations in a manufacturing GMP facility.
Experience applying process improvement tools and methodologies such as: DMAIC, LEAN/Six Sigma.
Strong background in international Quality System standards and medical product regulatory requirements such as ISO, FDA, MDD, etc.
Demonstrated practical risk management skills, including facilitation using risk management tools (e.g. FMEA, etc.)
Strong root cause analysis and problem solving skills at a tactical level.
Sound knowledge of validation principles.
Ability to interpret and relate Quality standards for implementation and review.
Ability to make sound decisions about scheduling, allocation of resources, and managing priorities.
Ability to communicate clearly and professionally both in writing and verbally.
Proficient PC skills to include Microsoft Office (Excel, Word, Outlook). Experience with MiniTab or similar is preferred.
A thorough understanding of medical manufacturing, its environment and requirements.
Collaborative Leadership – ability to influence, facilitate groups with diverse perspectives, bring teams to consensus/alignment. High tolerance for ambiguity, able to create order from chaos.
Ownership and Accountability – Takes accountability for actions, drives results, learns from mistakes. Is direct and truthful and therefore widely trusted – delivers on promises, goals and expectations. Makes decisions based on data and facts and resolves problems rapidly.
Communication – Ability to communicate effectively at all levels of the organization, present complex and/or new ideas with clarity and simplicity. Can speak, understand and write English.
Planning/Organization – Excellent planning and prioritization skills with the ability to multitask and adapt. Able to synthesize large amounts of information.
Analytical Problem Solving – Ability to identify problems, define problem statement clearly and accurately and apply structured and disciplined methodology to identify data-driven root causes. Innovative and effective in solution development, risk mitigation and execution. Ability to integrate Quality Systems to assure seamless flow of information and improve data utilization and interpretation across multiple teams.
Customer Focused – Partners with customers, ability to look ahead to predict future customer needs. Proactively manage expectations.
Evidence of Success: (Must be limited to two statements and must focus on critical HISTORICAL work performance of potential applicants. For an applicant to be considered for the job, they must show “evidence of success” in their previous jobs of delivering the results that are stated here. If an applicant would be hired despite not being able to show a history of this performance, then that item should not be stated here. These should be the absolute top two items that are critical for the selected for hire applicant must be able to show previous work historical success with.)
