Quality Engineer II (TAS)

Terumo•Davie, FL

1d•Onsite

About The Position

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. At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients. Join us and help shape wherever we go next! Advancing healthcare with heart www.terumoaortic.com

Requirements

Bachelor’s degree in a technical discipline (Mechanical/Biomedical/Electrical engineering), or equivalent, with a minimum of five years of experience in medical device quality assurance.
Minimum 1-3 years’ experience in Manufacturing Engineering or Quality Engineering with preference having validation experience.
Working knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) - ISO 13485 and ISO 14971).
Understanding of required standards / regulations impacting Medical Devices.
Leadership ability and organizational skills.
Strong team-oriented professional with good interpersonal skills who is hands-on with a high energy approach to work.
Must have experience handling nonconforming events.
Understanding of quality system regulations (ISO13485, 21CFR820)
Analytical skills for compiling and analyzing data.
Computer and software skills

Nice To Haves

Six Sigma Certification a plus
ASQ Quality Engineer Certification a plus
SAP knowledge is a plus

Responsibilities

Responsible for supporting the quality engineering operations of receiving inspection, in-process and finished product and maintaining processes and methods in accordance with the company standards.
Reporting on the performance of the assigned quality areas.
Responsible for maintaining regulatory compliance.
Develops quality standards and controls.
Develops product and process qualifications/validation protocols/reports for new products and existing manufacturing production lines.
Advises company management on quality assurance requirements.
Review non-conforming products along with product risk assessment and perform product failure investigations.
Drives Supplier and Production Quality improvements, including efficiency and productivity improvements while maintaining compliance.
Participates in the nonconformance process to ensure timely completion of documentation stages.
Identifies, Reports and Monitors Nonconforming events for the areas of responsibility.
Performs product or process failure investigations and implements corrective and preventive actions to prevent reoccurrence.
Interacts with cross-functional teams to resolve quality issues.
Quality control, product release authorizations, and quarantine of all suspect or discrepant product.
Develops Quality Instructions and Quality Standards.
Support in the development, validation, and implementation of Test Methods.
Suggests, implements, reviews, and approves engineering changes to support product life cycle.
Provides adequate QA support to the assigned areas and responds to Internal Audits, and takes actions as appropriate based on CAPAs, Complaint investigations, Nonconforming events, etc.
Supports the Corrective and Preventive Action (CAPA) System for Quality Operations-related activities.
Applies knowledge in Quality Systems to execute overall project assignments.
Applies statistical tools to analyze data and identify root cause and problem resolution.
Collaborates with Manufacturing, Product Support and R&D to support products for design and process improvements, and new equipment installations.
Recommends decisions on administrative or operational matters and ensures Quality Assurance(s) effective achievement of objectives.
Ensures quality system compliance for areas of responsibility.
Serve as a technical resource for assessing validation requirements, solving test related problems, and developing strategies for problem prevention.
Perform and lead risk assessment exercises in support of validation activities.
Drive Quality Systems improvement and implementation projects.
Oversees the Nonconformance process to ensure timely completion of documentation stages and drives monthly meetings.
Prepare, review, execute, and summarize validation protocols (IQ, OQ, PQ)