MDR Quality Engineer - Urgent Position

We are searching for a competitive MDR Quality Engineer to join our awesome team at Medical Devices Company in Louisville, CO.
Growing your career as a Full Time MDR Quality Engineer is a terrific opportunity to develop competitive skills.
If you are strong in persuasion, critical thinking and have the right initiative for the job, then apply for the position of MDR Quality Engineer at Medical Devices Company today!

Roles & Responsibilities

Essential Duties And Responsibilities:

• Develop, implement and maintain standards for software quality processes, systems and procedures to support the software life cycle
• Ensure that software project and process control documentation are compliant with established procedures
• Support Research and Development, Manufacturing, Production and IT in Software Quality Assurance
• Review product requirements for traceability, risk remediation and testability
• Review verification and validation deliverables for compliance with regulatory requirements
• Review software test harness / test cases for clarity and requirements coverage
• Preparation and analysis of periodic Quality Reports
• Perform internal and support external audits of products and processes
• Selection, qualification and monitoring of outside suppliers
• Preparation and review/approval of Engineering Changes and MRB Materials
• Collect, analyze and take action on performance measurement indices, statistical capability/ reliability analysis
• Enhance the Quality Management System in such areas as Design Review Process, Compliance to Standards, Change Management, Software BOM enhancements, and Device History File (DHF)
• Lead specific continuous improvements initiatives which will evolve into a more robust software quality assurance process. Track software problem reports and deviation up to closure
• Support the development, update, validation, and documentation of software utilized in the automated testing of printed circuit boards and finished medical devices
• Assist in maintaining, troubleshooting, and repairing software elements of automated test systems utilized in manufacturing and service
• Support IQ/OQ/PQ activities involving software-based manufacturing and service equipment
• Develop and maintain records for regulatory requirements related to EU MDR including Trace Matrix
• Coordinate with cross-functional teams to ensure mitigations are owned
• Estimate scope and project impacts for mitigation tasks

Experience Required

Familiar with the following standards and guidance documents:

• Quality System Regulations 21 CFR 820
• ISO 13485: 2003 Quality Management System
• IEC 62304: 2006 Medical Device Software Life Cycle
• ISO 14971: 2007 Medical Device Risk Management
• IEC 60601-1 2nd and 3rd Edition Medical Equipment / Medical Electronic Equipment Safety
• ANSI/AAMI/IEC 62366: 2007 Medical Device Application of Usability
• ANSI/AAMI HE 75 Medical Device Human Factors
• FDA Guidance on General Principles of Software Validation: Final Guidance for Industry and FDA Staff
• FDA Guidance on Applying Human Factors and Usability Engineering to Optimize Medical Device Design
• FDA Guidance for the Content of Premarket Submissions for Software Contained in a Medical Device
• Regulation (EU) 2017/745

Skills & Certifications

Education and/or Experience:

• Bachelor of Science Degree or equivalent experience
• 5 – 7 years of experience testing medical device software as well as establishing and upholding software life cycle processes
• 3 – 4 years of managing cross-functional teams in a project setting

Language Skills:

• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Mathematical Skills:

• Versed in statistics, modeling, optimization, data presentation and analysis and application to technical problems.

Physical Demands:

• May occasionally lift objects up to 25 lbs.

Work Environment:

• This position works in a normal office environment. The noise level in the work environment is quiet to moderate.

Eligibilities & qualifications

• To perform this job successful, an individual must be able to perform each essential duty satisfactorily.
• The requirements listed in this section and below are representative of the knowledge, skill and/or ability required.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Ability to perform engineering work of a broad nature with little direction from Quality Management. Generally, receives guidance on novel or controversial problems.
• Knowledge of medical device regulation, industry or international standard, including management responsibility.
• Ability to interface with regulatory bodies to present technical information.
• Knowledge of quality systems and relationship to business.
• Has experience in writing process, software, and equipment protocols/validations and has fundamental knowledge of validation principles.
• Ability to participate and provide leadership on teams and maintain positive work environment with those teams.
• Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience.
• Understands Fundamentals of Engineering Principles.
• Ability to effectively manage time.
• Ability to handle multiple task assignments.
• Ability to translate quality requirements into product specifications.
• Ability to interpret Regulations, Corporate, Division and Department Procedures.
• Ability to manage project expectations related to mitigation tasks and gap assessments

 

Benefits of working as a MDR Quality Engineer in Louisville, CO:

● Company offers great benefits
● Company offers career progression opportunities
● Competitive salary