Quality Engineer II

The Quality Engineer II is responsible for leading activities concerned with the application and maintenance of the Quality Management System for products and services offered by performing the essential functions and basic duties outlined in this job description. Other responsibilities include interfacing with internal and external customers on quality related aspects of development and sustaining projects.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

General:

• Follow Employee guidelines and Quality System Regulations as defined by Nissha Medical Technologies, policies and Standard Operating Procedures to ensure that customer requirements and industry standards and or regulations are met.
• Demonstrate knowledge and act in accordance with NMT's Employee Guidelines and applicable quality standards as outlined in NMT's Quality Manual.
• Abide by all safety and security rules set forth by the company and regulatory agencies.
• Regular attendance is required.

Quality Assurance:

• Ensures compliance with cGMP and established procedures in all areas of the company.
• Supports and establishes quality standards for products, processes, and procedures.
• Prepare business reports for the customer and company, as required.
• Provide support for design and development activities, including development of FMEAs and Control Plans.
• Backup for other department functions as needed.

Problem Solving:

• Demonstrates proficiency to investigate and analyze manufacturing, customer, and supplier problems.
• Manage and investigate customer complaints, including DHR reviews.
• Own supplier control nonconformances and SCARs as necessary.
• Initiate and own CAPAs as necessary.
• Demonstrates an ability to troubleshoot line manufacturing, supervision, and engineering activities.

Analysis:

• Demonstrates an ability to perform and support capability studies, GR&Rs, and first articles.
• Determine and implement the test facilities and inspection required for quality assurance activity and methodologies.
• Support and analyze outside service testing for internal and external customers (i.e. bioburden, sterilization, environmental monitoring).
• Supports and leads the development of plans to evaluate process repeatability and stability through equipment qualification and process validation. Apply appropriate statistical methodologies.
• Assist with material compliance requests as assigned (REACh/RoHS/etc.).
• Lead internal open item and company metric review meetings where assigned.

Continuous Improvement:

• Implement process improvements including fixtures, tools, production checks, testing, and inspection of devices.
• Create, review and revise documentation and standards pertinent to production, design, and development.
• Establish systems of measurement to improve the efficiency and adaptability of the business and production processes.

Audits:

• Participate in internal and external audits.
• Acts as lead contact for customer audits.

Documentation:

• Define and generate required documentation in support of assigned customer products and processes. These may include: Change orders, Engineering protocols, FMEAs, Control Plans, deviations, reports, work instructions, and procedures.
• Maintain a high level of documentation that is clear and understandable, contains pertinent and accurate information, and will promote confidence with customers and auditors.
• Responsible for training employees to new and updated documents and procedures where appropriate.

• Bachelor's Degree or equivalent experience/education
• Minimum of 3 years of related experience, Medical Device preferred
• Familiarity with Quality Systems and regulatory agencies. Preferably ISO 13485 and FDA 21 CFR 820
• Certification through ASQ as a CQE preferred
• Highly organized, detail oriented and works effectively as both a team member and independent contributor
• Demonstrated proficiency in MS Suite, particularly MS Word and Excel
• Knowledge of Minitab preferred
• Ability to work independently, at times with minimal supervision
• Acts with sound and proactive decision making, seeks clarification as appropriate to minimize/eliminate delays
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals
• Ability to write routine reports and correspondence
• Ability to apply logical and systematic understanding to carry out instructions furnished in written, oral or diagram form.
• Ability to deal with problems involving several concrete variables in standard situations