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

Benefits / Compensation

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. $73,000 - $105,000