Quality Engineer Technician - Innovize : Job Details

Job DescriptionTitle: Quality Engineering Technician Reports to: Manufacturing Engineering Manager Summary: This position is responsible for providing technical support for the quality engineering team. These duties include but are not limited to: blueprint assessment, GD&T assessment, time studies, quality plan development and IQ/OQ/PQ execution. The QE Technician will participate in engineering problem solving, CMM inspection program troubleshooting, root cause investigations of product and process issues, customer complaints, and documenting the findings. Duties/Responsibilities include but are not limited to:

• 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

Accountabilities:

• 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

Training/Education/Experience:

• 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

Competencies/Talents/Personal Attributes:

• 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

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.)

• 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