Quality Ops Engineering Analyst II

At Terumo Aortic, our mission is to transform the treatment of aortic disease worldwide. With our comprehensive portfolio of surgical, endovascular and hybrid technologies, we enable physicians to find the right fit for each patient anatomy.

The company has over 1,250 associates around the world with manufacturing facilities in Glasgow, Scotland and Sunrise, Florida.

Terumo Aortic is focused on the continuing development of new and innovative products driving the growth of the business globally. Associates are part of a stimulating and exciting environment in which they can develop their skills and achieve career goals. Working for the company, each associate’s role contributes greatly to helping to save or improve the lives of patients in over 100 countries worldwide.

www.terumoaortic.com

Job Summary:

The QE Analyst will support activities related to the non-conforming product process and other departmental operating activities by collecting and analyzing data from the NC process, recommending and implementing solutions and fixes to recurring and novel manufacturing issues. Additionally, this position is responsible for supporting all activities related to Quality Operations.

Job Details for QE Analyst:

• Receives, evaluates and makes decisions regarding nonconformance legitimacy and completeness, interfacing with technicians, engineers and other constituents.
• Recommends, implements, and monitors preventative and corrective actions to ensure quality assurance standards are achieved.
• Compiles NC information performs data analysis and communicates the results (metrics) to the organization on a regular basis to drive continuous improvement in NC processes.
• Maintains records of required as part of the Quality System inclusive of the NC log and any other records as required.
• Reviews NC documentation submissions for completeness, accuracy and relevance to the event.
• After evaluation and completion, routes NC documentation for final review and approval.
• Changes material status in the ERP systems.
• Assists with administrative functions and supports other department tasks as needed.
• Participates in project performance team meetings on behalf of the job unit in order to provide ideas, methods or processes for unit/company performance improvement.

Position Requirements:

• Knowledge, Skills and Abilities
  • Effective verbal and written communication and organizational skills.
  • Strong analytical skills with the demonstrated ability to use data to get at root causes, draw appropriate conclusions around problem resolution and the ability to influence and follow through on suggested corrective actions.
  • Demonstrated Quality mindset: process oriented, root cause oriented, customer oriented, sense of urgency, accountability, and responsibility.
  • Ability to use testing equipment (i.e. calipers, micrometers, microscope, optical comparator, Instron, Laser Mic, Lubricity Tester, etc.).
  • Mathematical knowledge and aptitude, including algebra and utilization of sampling plans/statistical charts.
  • Requires ability to notice trends and escalate situations/problems to supervisor.

• Background Experience
  • Required: 3 years prior experience in technical engineering, quality assurance, manufacturing support, or related.
  • Requires a High School Diploma, Associates Degree Preferred.

It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.