Supervisor, Quality control (TAS)

Terumo•Davie, FL

4d•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

BS in Engineering or more than 5 years in the Medical Device industry with more than 5 years of experience in the quality field.
Familiarity with management of non-conforming product.
Familiarity with sampling plans, and failure analysis investigations.
Excellent Written and Verbal Communication
Understanding of quality system regulations (ISO13485, 21CFR820)
Ability to interact with all levels within organization.
Analytical skills for compiling and analyzing data.
Knowledge of sampling plans
Computer and software skills
Ability to motivate others and improve efficiency.

Responsibilities

Supervises a team of several inspectors in the Quality Control Operation Areas.
Must be able to analyze trends and recommend appropriate changes to sampling plans, procedures, inspections methods, or tooling.
Recommends modifications / improvement where advisable to minimize cost and labor.
Coordinates and participates in audits whether that be internal or external to ensure quality compliance.
Must be able to evaluate and implement changes for efficiency and effectiveness of inspections.
Analyzes and investigates both in house and field data, reports quality problems, recommends corrective action, and follows up on the implementation and effectiveness of solutions.
Assure responsibilities are carried out in compliance with applicable quality systems (i.e.ISO13485, 21CFR820).
Interface with Research and Development and other engineering departments to determine if process or product changes are needed based on NCR investigations.
Requests and confirms corrections, corrective actions, and/or preventive actions from suppliers, engineers (as needed) to ensure that non-conformances are properly corrected, and recurrence is prevented.
Updates Quality procedures/documents as needed to ensure efficient workflow and appropriate use of equipment/tools, and sampling plans.
Facilitates inspector training and ensures relevant training requirements are up to date.
Manages non-conformance report generation, tracking and closure.
Ensure compliance with all quality systems regulatory requirements such as, but not limited to, ISO 13485, 21 CFR Part 820, MDSAP, MDD (93/42/EEC) and MDR (EU 2017/745)
Responsible for addressing issues within the QMS without undue delay as evidenced by on time completion of actions on the Single Action Tracker (SAT)
Ensure compliance with all quality systems regulatory requirements such as, but not limited to, ISO 13485, 21 CFR Part 820, MDSAP, MDD (93/42/EEC) and MDR (EU 2017/745).
Responsible for addressing issues within the QMS without undue delay as evidenced by on time completion of actions on the Single Action Tracker (SAT).
Provide recourse to meet Environmental Health and Safety goals.
Maintain defined organisation Environmental Health and Safety competencies.
Ensure related Risk Assessments are completed, accidents raised and action hazards