Supervisor, Quality Control (TAS)

Terumo Cardiovascular Group; Florida; Vor Ort; USD 72.000 - 100.000; Vollzeit

Zusammenfassung

Terumo Aortic is seeking a Quality Operations supervisor to lead inspectors, analyze NCRs, and ensure compliance with ISO 13485 and 21 CFR 820. The role involves coordinating audits, driving process improvements, and collaborating with R&D to implement corrective actions.

The position demands a BS in Engineering or equivalent medical device quality experience, strong analytical abilities, and the ability to motivate teams while improving efficiency.

Qualifikationen

• BS in Engineering or 5+ years in Medical Device quality.
• Familiarity with management of non-conforming product.
• Familiarity with sampling plans and failure analysis investigations.

Aufgaben

• Supervises a team of inspectors in Quality Control Operation Areas.
• Analyzes trends and recommends changes to sampling plans, procedures, inspections methods or tooling.
• Recommends modifications to minimize cost and labor.
• Coordinates and participates in internal or external audits to ensure quality compliance.
• Evaluates and implements changes for efficiency and effectiveness of inspections.
• Analyzes and investigates data, reports quality problems, and follows up on corrective actions.
• Ensures compliance with ISO13485, 21 CFR 820 and related QMS requirements.
• Interfaces with R&D and engineering to determine need for process/product changes from NCRs.
• Requests and confirms corrective actions from suppliers/engineers to prevent recurrence.
• Updates Quality procedures and sampling plans as needed.
• Facilitates inspector training and ensures training is up to date.
• Manages non-conformance report generation, tracking and closure.

Kenntnisse

Analytical skills

Interacting with all levels

Computer and software skills

Motivate others / improve efficiency

Knowledge of sampling plans

Ausbildung

BS in Engineering

Jobbeschreibung

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!

Provides technical, clerical, and logistical support to the Quality Operations program. Supervises inspectors in Quality Control Operations Areas to ensure continuous workflow and appropriate use of sampling plans and tools, as applicable. Works with other departments on the development and execution of equipment and / or test method validations. Analyzes and investigates non-conformities, and triggers CAPA escalations as needed.

• 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.

Job Responsibilities (continued)

Quality requirements:

• 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)

EH&S Requirements:

• 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

Knowledge, Skills and Abilities (KSA)

• 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.

Qualifications/ Background Experiences

• 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.

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. Salary - $72,000 to 100,000

Nearest Major Market: Fort Lauderdale
Nearest Secondary Market: Miami