Quality Engineer II

Terumo Aortic; Town of Florida (NY); On-site; USD 85,000 - 130,000; Full time

Job summary

Terumo Aortic in Sunrise, FL is seeking a Quality Engineer to support receiving, in-process, and finished product quality operations. You will develop quality standards, review nonconformances, and drive CAPA, risk assessments, and investigations.

The role collaborates with Manufacturing, R&D, and Product Support to enable design and process improvements while ensuring regulatory compliance and quality objectives are met.

Qualifications

• Knowledge of quality system regulations (FDA/ISO) and associated compliance expectations.
• Ability to analyze data, interpret trends and drive corrective actions.
• Experience with validation protocols (IQ/OQ/PQ) and product/process qualification.
• ASQ Quality Engineer Certification a plus.

Responsibilities

• Support quality engineering operations for receiving, in-process, and finished product.
• Maintain regulatory compliance and develop quality standards and controls.
• Review nonconforming products and perform risk assessments and investigations.
• Lead CAPA processes and cross-functional quality improvements.
• Collaborate with Manufacturing, Product Support and R&D for design and process improvements.

Skills

Quality systems

ISO13485

FDA 21 CFR 820

DOE

SPC

Gage R&R

Education

Bachelor's degree in Mechanical/Biomedical/Electrical engineering or equivalent

Job description

Join us and help shape wherever we go next!

Advancing healthcare with heart

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.

Job Summary

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.
• Additionally, this role may also have some or all the following responsibilities (based on specific role within the organization):
• 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)

Working Conditions/Physical Requirements

Quality Requirements:

• Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives.
• Work within the QMS always, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality.
• Responsible to ensure facility, processes and documentation always remain in a state of audit readiness.

EH&S Requirements:

• Take care of your own health and safety and that of others who may be affected by your actions.
• Work co-operatively to highlight issues affecting Environmental Health and Safety

Knowledge, Skills and Abilities (KSA)

• Works with all levels within the company.
• Ability to organize and conduct multiple, parallel tasks.
• Understanding of quality system regulations (ISO13485, 21CFR820)
• Ability to interact with all levels within organization.
• Analytical skills for compiling and analyzing data.
• Mechanically inclined
• Knowledge of DOE, SPC, Gage R&R, and sampling plans
• Computer and software skills
• Ability to motivate others and improve efficiency.
• ASQ Quality Engineer Certification a plus
• Statistics and data analysis.

Qualifications/ Background Experiences

• 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.