Quality Engineer

Job Description

Title: Quality Engineer

Reports to: Quality Engineering Manager

Schedule : Day Shift/ Mon - Fri

Pay: Exempt 5% annual bonus

Summary: Primary duties will be to work with quality, production engineering, manufacturing and customers to develop and document quality plans, work and inspection procedures, write equipment and process qualification plans and reports, assisting in the performance of complaint investigations and corrective actions. Additional duties include identifying improvement opportunities and assisting the Continuous Improvement department with implementing manufacturing cost reduction opportunities. Using technical writing and analytical skills, assists with quality improvements for new and existing manufacturing and inspection processes. Develop and implement successful quality improvement methods and practices internally and externally with customers and suppliers.

Duties/Responsibilities include but are not limited to:

• Works within the Customer Focused Team (CFT) to identify and implement effective controls to support the development, qualification, and manufacturability of products to meet or exceed internal and external requirements.
• In support of CFT process development, perform process capability studies, Gage R & R studies, create control plans, FMEA, DOE and other quality documentation requested by Innovize customer's and/or required for internal use.
• Working with CFT project management, engineering, business development managers and production associates to develop inspection and test methods, equipment qualifications and process validation protocols in support of process development.
• Assist Quality team associates in the creation of receiving inspection instructions.
• Represent Quality team in project meetings and completing assigned tasks on time.
• Identify and implement inspection methods and equipment to reduce cost and improve productivity.
• Accountable for analyzing data, establishing methods and implementing process changes to reduce the frequency of non-conformances.
• Create, analyze and drive corrective actions to completion.

Accountabilities:

• Accountable for meeting the company safety goals.
• Accountable for meeting the company product and service quality goals.
• Accountable for writing and conducting equipment (IQ, OQ and PQ), process qualification activities and relevant supporting documentation. Write equipment operating procedures and exams.
• Accountable for quarterly goal for CAR's, acceptable root cause is complete within 12 business days.
• Accountable for projects and project revenue.
• Accountable to achieve goal for profit contribution dollars.
• Accountable for work habits verifications.
• Accountable for learning and development
• Accountable to achieve goal for Recognition.

Training/Education/Experience:

• Four-year Bachelor of Science/Engineering degree
  • Alternatively, a demonstrable 10-years of progressively responsible work experience in a technical manufacturing Quality role supporting Quality Engineering
  • Or a two-year technical degree and demonstrable 6-years of progressively responsible work experience in a technical manufacturing Quality role supporting Quality Engineering
• 2 years of medical manufacturing experience (may include internship experience)
• Experience in an automated manufacturing and testing environment. Rotary converting a plus.
• ASQ Certified Quality Engineering certificate highly desired.
• Proficient PC skills in MiniTab and Microsoft Office.
• Experience using CAD software highly desirable.
• Able to utilize GD&T software packages highly desirable.
• Experience in a fast paced custom development and manufacturing environment.

Competencies/Talents/Personal Attributes:

• Good communication skills, both written and verbal.
• Strong math skills with ability to understand descriptive and inferential statistics.
• Ability to read blueprints, recognize UL specifications and understand geometric dimensioning and tolerancing (GD&T).
• Demonstrates abasic understanding of ISO 13485 and GMP requirements through active participation in training programs and using the information as guidelines in technical writing to insure ongoing compliance.
• Ability to understand material characteristics, tooling specifications, equipment, and how materials, tooling, and process settings interact to affect the overall tolerance capability of various product designs.
• Ability to balance the requirement for meeting customer expectations and FDA regulations with company profitability in supporting the Quality Technician in developing estimates for work and inspection instructions.
• Excellent attention to detail.
• Basic understanding and application of SixSigma (DMAIC) manufacturing concepts and Lean concepts.
• Ability to determine appropriate inspection tools to be used i.e. fixtures, templates, coordinate measuring machine, and go-no go gauges, etc.
• Ability to create and sustain effective relationships both internally and externally.

EOE Minorities/Females/Vet/Disability Innovize is a drug and alcohol free workplace.
Pre-employment screenings are conducted. Applicants who need a reasonable accommodation to complete this application should contact Innovize HR @ 651-490-0000.

To view our Equal Employment Opportunity and Affirmative Action Statement, Click Here.

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