|Location:||Colorado Springs, CO|
Nissha Medical Technologies is looking for a Quality Engineer to join our Colorado Springs Team. This position 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 customers on quality related aspects of projects.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- 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.
- Investigate and analyze manufacturing, customer, and supplier problems.
- Support the establishment of quality standards for products, processes, and procedures.
- Perform capability studies, GR&Rs, and first articles on products and design and development Control Plans.
- Participate in FMEA, DFM, and Validation Activities
- Implement process improvements including fixtures, tools, production checks, testing, and inspection of devices.
- Assist in troubleshooting line manufacturing, supervision, and engineering activities.
- Review documentation and standards pertinent to production, design, and development.
- Help determine and implement the test facilities and inspection required for quality assurance activities.
- Establish systems of measurement to improve the efficiency and adaptability of the business and production processes.
- Prepare business reports for the customer and company, as required.
- Participate in internal and external audits.
- Back up for other department functions as needed.
- Abide by all safety and security rules set forth by the company and regulatory agencies.
- Regular attendance is required.
- Other duties as assigned.
- Bachelor’s Degree (BA or BS) from a four-year College or University
- 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 time 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
Nissha Medical Technologies is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, national origin, age, disability, marital or veteran status, sexual orientation, or any other legally protected status. In addition, NMT will provide reasonable accommodations for qualified individuals with disabilities.
If you need assistance with completing the online application process, please call (719) 426-9074.