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.
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 is preferred.
Skills Required
- Minimum 8 years of experience in a medical manufacturing quality environment
- Four-year bachelor's degree
- Direct experience supporting operations in a GMP manufacturing facility in a Quality role
- Experience applying DMAIC and Lean Six Sigma process improvement methodologies
- Strong background in international Quality System standards and medical product regulatory requirements, including ISO, FDA, and MDD
- Practical risk management skills, including facilitation with FMEA and related tools
- Strong tactical root cause analysis and problem-solving skills
- Knowledge of validation principles
- Ability to interpret and apply Quality standards
- Ability to make decisions regarding scheduling, resource allocation, and priorities
- Clear and professional written and verbal communication skills
- Proficiency with Microsoft Office, including Excel, Word, and Outlook
- Quality Engineering certification
- Experience with Minitab or similar software
What We Do
Innovize is a medical contract manufacturer supporting the full product lifecycle, from concept and development through packaging, full-scale production, and product evolution. The company manufactures subassembly components and complete devices for personal care, patient care, diagnostics, and other life-science applications. It emphasizes tailored solutions, regulatory compliance, and ISO 13485:2016-certified processes for customers operating in regulated healthcare markets.
