Quality Engineer Technician
Innovize
- Saint Paul, MN
- $28.03-42.05 per hour
- Permanent
- Full-time
- Assist the quality engineers with product/process issue and customer complaint investigations
- Assist quality engineers with the creation, editing, and execution of manufacturing, inspection and test methods and instructions
- Assist quality engineers with protocol execution, process time studies, process risk assessment, control plan development, and process improvement identification and implementation
- Assist quality engineers with equipment qualifications (IQ/OQ/PQ)
- Assist quality engineers with Manufacturing Transfer activities (documentation, testing, etc.)
- Assist quality engineers with writing work instructions and training associates
- Comply with GMP, ISO13485, and FDA requirements
- Understand and assist production associates with accurate print reading and interpretation
- Complete other duties as assigned
- Accountable for meeting company Safety goal
- Accountable for meeting the company On-Time Delivery goal
- Accountable for meeting the company Customer Satisfaction goal
- Accountable for meeting the company Cost of Quality goal
- High School education or equivalent and 2 years of trade school in technical field or equivalent work experience
- Experience with or ability to learn IQ/OQ/PQ validation activities, preferably for medical products
- Experience with or ability to learn regulatory requirements like ISO, GMP, FDA, CAPA, and others
- Experience with or ability to learn Lean Six Sigma Manufacturing methodology
- Proficient PC skills, Microsoft
- Minitab or similar statistical package experience preferred
- CAD package experience preferred
- CMM programming experience preferred
- GD&T expertise preferred
- Excellent communication skills, written and verbal, with ability to consistently comply with documentation requirements
- Demonstrates initiative and independence: Proactively seeks new opportunities and exhibits self-confidence; is action oriented and makes things happen, despite apparent roadblocks
- Consistently demonstrates a positive professional demeanor and level-headedness
- Able to work cooperatively and supportive with customers, sales, engineering, quality, and production
- Demonstrates organization, planning, and follow-through
- Strong applied math skills
- Demonstrates a commitment to comply with ISO13485 and FDA regulations
- Ability to read blueprints and to understand geometric dimensioning and tolerances (GD&T)
- Ability to work effectively on computers, to collect data, to create graphs, to create process flow diagrams, and to create press diagrams
- Can speak, understand, and write English
- Able to identify examples of personal leadership and technical contributions
- Able to provide examples of "can do" positive attitude and successful outcomes for challenging projects with tight timelines