Supplier Quality Engineer/Manufacturing Engineer High Throughput Genomics
THIS JOB HAS EXPIRED Job Duties:
Assess supplier capability and quality control plans.
Perform supplier compliance assessments as well as working with Incoming Inspection to set up component assurance testing.
Drives resolution of supplier quality issues.
Ensures NCR and CAPA items addressed in a timely manner and corrective actions prevent recurrence of issue.
Builds strong productive relationships with Suppliers, Sourcing, Operations,Research & Development and Quality Systems teams to maintain a reliable supply chain of products, components and services that consistently meet or exceed HTG?s requirements.
Responsible for utilizing effective and efficient Quality Engineering techniques, such as risk analysis, test method development, design of experiments, statistical data analysis, measurement system analysis, and development of sampling plans throughout the product lifecycle.
Write, negotiate and ensure timely execution of Quality Agreements and Control Plans for external manufacturers and key suppliers/service providers that clearly define quality objectives and ensure consistent delivery of critical to quality elements.
Work with Quality Systems to develop, implement and execute compliant and efficient supplier quality management processes.
Provide Supplier Quality Engineering leadership to sustaining and new product development projects.
Provide technical leadership in manufacturing process development/improvement and sustaining efforts of a GMP manufacturing environment.
Work with R & D, Quality Systems, Operations and other groups to develop processes for new products, sustain and improve processes for existing products, and transfer processes and products globally.
Participate in process sustaining, definition and improvement, design, development and quality test activities for all HTG products.
Troubleshoot production line issues related to yield, quality and throughput.
Assist in customer complaint investigations.
Construct and execute controlled experiments (including DOE?s) to optimize processes, address yield and quality issues and drive implementation of solutions in a production environment to meet production goals.
Analyze process test results, issues reports and make technical recommendations.
Represent manufacturing needs on development teams.
Define technical requirements and write procedures for manufacturing to process HTG products.
Minimum Job and Qualification Requirements:
B.S./M.S./ PhD in Biology, Biochemistry, or Biomedical Engineering.
Minimum of 5 years of relevant experience in medical device manufacturing support/sustaining and process definition, design, scale-up, improvement and validation.
Basic math and principles of experimental methods
Microsoft Office (Word, Excel, PowerPoint, Outlook), e-mail
Ability to write test protocols, read and interpret assay protocols, instrument operating manuals, Material Safety Data Sheets, etc.
Ability to use/implement Statistical Process Control and DOE techniques.
Good interdepartmental communication skills and documentation skills.
The position is primarily sedentary but, requires the ability to move objects weighing up to 50 lbs.
This position works closely with the Quality Systems functional group and will at times be directed by that group. This position reports to the VP of Operations with a dotted line reporting relationship to the Manager of Quality Systems.
||6296 East Grant Road |
Tucson, AZ 85712
THIS JOB HAS EXPIRED