Quality Engineer II (2nd shift, 4 10's) Date: Nov 6, 2024 Req ID: 3992 Location: Elkton, MD, US Company: Terumo Medical Corporation Department: Quality Engineering II Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come. 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** The Quality Engineer II position will work closely with the Operations and Engineering Team to ensure that goods are designed, developed, and made to meet or exceed our customer expectations and requirements. The position will support production and project activities and drive continuous improvement. Ensure compliance to Terumo’s quality policy, respond to customer complaints, perform audits, develop test methods, and/or write procedures for material characterization. **Job Details/Responsibilities** 1. Proactively investigates, identifies, and implements best-in-class Quality Engineering practices. 2. Provide focused quality engineering support and assume responsibility for timely and effective coordination and/or execution of assigned development project activities. 3. Establish effective corrective action plans. Lead in implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements. 4. Acts as an effective project lead or team member in supporting quality disciplines, decisions, and practices. 5. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. 6. Identify non-conformance trends and develop technical investigation plans. Investigates and analyzes customer/internal complaints. 7. Performs data analysis and executes experiments to qualify or resolve product and process issues. 8. Creates, reviews, and approves internal documentation such as quality plans and standard operating procedures. 9. Develop product/process assurance plans, which include all required elements. Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements 10. Responsible for developing and implementing master validation plans, validation protocols, inspection plans and quality/regulatory compliance operating procedures to meet FDA (Food and Drug Administration) and ISO (International Organization of Standardization) requirements. 11. Provide training and support for quality system processes and quality engineering practices. 12. Perform other job-related duties. **Knowledge, Skills and Abilities (KSA)** + Knowledge of national and international regulations applicable to medical devices including Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDD 93/42/EEC + Communication proficiency; verbal and written. + Problem Solving and Critical Thinking + Detail Oriented + Initiative + Decision Making + Results Oriented; self-motivated and self-driven + Excellent organizational and time management skills. + Excellent computer skills + Good writing, mathematics, and statistics skills. **Qualifications/ Background Experiences** + Bachelors degree (4 years) or higher from an accredited course of study, in engineering, engineering technology, computer science, mathematics, or physics + Requires at least three (3) years experience in a medical device or highly regulated industry. + Experience working in a manufacturing environment preferred + One year of auditor experience preferred + Certification as a CQA; CQE or CQM and member of the ASQ is preferred **Compensation and Benefits** We provide competitive and comprehensive benefit options that allow you to design your own plan based on your individual needs which include: 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. The salary range for this position is $71,400 - $107,200 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.