Quality Systems Engineer II (TAS)
Sunrise, FL, US, 33325
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
Job Summary
Job Details/Responsibilities
Quality engineering, system and process validation, project team leadership and participation, document generation and control, data analysis, corrective and preventive action.
a) Prepares and implements quality standards, operating procedures, inspection and test procedures and reporting systems.
b) Being responsible for approving corrective and preventive action plans, implementation of required activities and objective evidence and effectiveness verification
c) Supports CAPA and auditing programs and performs assigned actions to address quality issues.
d) Leads CAPA Monthly meetings and organizes stewardship reviews of CAPA documentation
e) Establishes and maintains CAPA metrics
f) Reviewing content of CAPA root cause investigations, corrective actions, effectiveness criteria and compliance to regulatory and procedural requirements
g) Interacts with cross-functional teams to obtain system requirements and feedback to implement preventive and/or corrective actions.
h) Reports and presents status of assigned projects to the management team. Identifies areas of risk and recommends mitigation actions.
i) Prepares and implements proposals for improvement to the quality management system. Provides follow-up actions as necessary.
j) Develops quality plans, validation plans, risk assessments and other validation related deliverables for the implementation of electronic quality management systems.
k) Ensures quality system compliance for areas of responsibility.
l) Reviews, approves changes under the change management system, as required.
m) Initiate investigations and product performance risk analysis for nonconforming products and the quality management system.
Job Responsibilities (continued)
Working Conditions/Physical Requirements
Knowledge, Skills and Abilities (KSA)
b) Understanding of quality system regulations (ISO13485, 21CFR820)
c) Understanding of Computerized System Validation requirements for Medical Devices (21CFR Part 11).
d) Ability to interact with all levels within organization.
e) Analytical skills for compiling and analysing data.
f) Mechanically inclined
g) Knowledge of DOE, SPC, Gage R&R, and sampling plans
h) Computer and software skills
i) Ability to motivate others and work independently.j)
Qualifications/ Background Experiences
- Bachelor’s degree in a technical discipline, or equivalent, with 3+ of experience in medical device quality assurance.
- Experience with class III cardiovascular medical devices,
- Thorough understanding of quality system regulations (e.g. 21CFR820, ISO 13485)
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.
Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program.
Nearest Major Market: Fort Lauderdale
Nearest Secondary Market: Miami