Sr Quality Engineer
$90,000–$120,000 year
On-siteSaint Paul, Minnesota, United States
Job Summary
Develop and maintain quality engineering methodologies, systems, and practices that meet customer requirements while ensuring manufacturing and test process development for new products. Lead testing and validation of customer product designs, apply systematic problem-solving to resolve quality issues, and prepare regulatory plans including risk analysis for FDA, ISO, and MDD compliance. Create and maintain regulatory product files, notify management of potential compliance issues, and identify process improvements to support team functions. Manage competing priorities, serve as a technical subject matter expert on quality systems, and drive successful deployment of business processes and training.
Required Qualifications
- 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
- 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
Desired Qualifications
- Quality Engineering certification preferred
- Experience with MiniTab or similar
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