Quality Engineer Jobs

About The Position

Requirements

• 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.
• Can show historical evidence of successfully overseeing the manufacturing processes for FDA regulated products that have been validated.
• Can show historical evidence of success that Device History Records were accurate and that products were manufactured according to the customer’s Device Master Record.

Nice To Haves

• Quality Engineering certification preferred
• Experience with MiniTab or similar is preferred

Responsibilities

• 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.
• Identify, design, and implement process and system improvements.
• Serve as a technical subject matter expert (SME) on quality systems, processes, and issues in support of team functions.
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Manage competing priorities and maintain accountability for deliverables affecting team and organizational objectives.
• Set personal performance goals and collaborate with management to establish organizational objectives

Benefits

• Accountable to meet safety goal.
• Accountable to achieve product and service quality goal.
• Accountable for equipment installation and operational qualification.
• Accountable for closing assigned customer corrective actions within twelve business days.
• Accountable for projects and project revenue.
• Accountable to achieve goal for profit contribution dollars.
• Accountable for passing work habits verification with no findings.
• Accountable for meeting or exceeding utilization requirements of the Recognition Program.
• Accountable for learning and development.