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:
Responsible for supporting the quality control 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.
Job Details/Responsibilities:- 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.
- 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.
- 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)
Job Responsibilities: (continued) Working Conditions/Physical Requirements
Knowledge, Skills and Abilities:
(KSA) 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. 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.
Qualifications/ Background Experiences:
A bachelor's degree or equivalent experience in Engineering, Quality Engineering or Sciences.8+ years of related experience in a regulated environment in Quality Assurance and or Manufacturing/ Engineering environment. Must have experience handling nonconforming events. Packaging/Labelling 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. 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.
