Operations Manager – Quality Assurance

Terumo Aortic

Posted on: November 23, 2021

Closing: December 23, 2021

Salary: Undisclosed

Position Type: Full Time

Job Description

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.

Position Summary

Responsible for supporting the quality operation staff in the 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. Management of QA/QC staff, GMP and ISO compliance.

Key Accountabilities

    • Manages Production Quality staff overseeing Receiving Inspection, Cleanroom, and Final Release areas, including all inspectors, analysts, and technicians that report into the supervisors of those areas.
    •  Identifies, Reports and Monitors Nonconforming events for the Receiving, Cleanroom, Final Packaging and Release areas
    • Performs product failure investigations and implements corrective and preventive actions to prevent reoccurrence
    • Identifies and implements continuous improvement opportunities in all areas to ensure high quality and production efficiencies.
    • Oversees the continuous reduction of non-conformance reports and to ensure the proper control of any product under investigation.
    • 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.
    • 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, Complaints investigations, Nonconforming events, etc.
    • Supports the Corrective and Preventive Action (CAPA) System.
    • Identifies and evaluates fundamental compliance issues for major functional areas through assessment of quality system compliance.
    • Establishes Quality Assurance objectives and assignments, and delegates assignments to subordinates.
    • Involved in executing company policies.   
    • Recommends decisions on administrative or operational matters and ensures Quality Assurance(s) effective achievement of objectives.

Minimum Experience

    • This position requires cooperating with different company departments, such as Customer Service, Regulatory, Operations, Logistics, R&D Engineering and the other team members of the department.
    • Minimum Skills & Capabilities:
    • Works with all levels within the company.
    • Strong communication skills (written and oral)
    • Ability to organize and conduct multiple, parallel tasks
    • Ability to seek and utilize varied resources
    • Ability to influence others
    • Minimum Knowledge & Experience required for the position:
    • A Bachelor’s degree or equivalent experience in Engineering, Quality Engineering or Sciences.
    • Understanding of medical device design and process controls per FDA Quality System Requirements (QSRs) and ISO 13485.
    • 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.
    • 8+ years of related experience in a regulated environment in Quality Assurance and or Manufacturing/ Engineering environment.
    • Must have experience handling nonconforming events
    • Packaging/Labeling process experience is a plus
    • SAP knowledge is a plus

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.

Terumo Aortic

Posted on: November 23, 2021

Closing: December 23, 2021

Salary($): Undisclosed

Position Type: Full Time

Career Focus: Operations, Quality

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