Quality Assurance Engineer - Medical Devices

Understanding of, and/or experience with, medical device regulations, including EU MDR, ISO 13485, and IEC 62304, as well as the changes needed to keep medical devices compliant with new and evolving regulations. Expert-level process development skills, with the ability to create quality system documents for a wide range of users and product types, including software and AI-enabled applications.

Primary Talent Partners has a new contract opening for a Quality Assurance Engineer - Medical Devices with our medical device client in Lafayette, CO. This is a 6-month contract with a potential for extension.


Pay:$45.00 - $55.00/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment. Candidates must be legally authorized to work in the United States and must be able to sit on Primary Talent Partners W2 without sponsorship.


Description:
Responsibilities may include the following and other duties may be assigned:

• Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures.
• Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.
• Defines appropriate measures to ensure product quality.
• Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives.
• Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts.
• Reviews software systems design, change specifications, and plans against contractual and/or process requirements.
• Reviews include applicable specifications, materials, tools, techniques, and methodologies.
• Provides or directs verification and validation of software system requirements, traceability, and testability.

Must Have:

• Computer and software validation
• Change control of Medical Devices
• Understanding of, and/or experience with, medical device regulations, including EU MDR, ISO 13485, and IEC 62304, as well as the changes needed to keep medical devices compliant with new and evolving regulations.
• Understanding of non-medical product development processes and lifecycle requirements.
• Serve as the voice of the Software Systems function on deliverables, providing guidance to cross-functional team members from a software and systems perspective.
• Expertise in training development and delivery.
• Broad understanding of how medical devices are developed, regulated, and approved in the European Union and the United States.
• Familiarity with, or the ability to quickly learn, evolving medical device regulations, including emerging AI-related standards and requirements.
• Expert-level process development skills, with the ability to create quality system documents for a wide range of users and product types, including software and AI-enabled applications
• a Design Quality Engineer', 'Advanced understanding of design controls, quality system regulations, and failure investigation process and methodologies.
• Apply knowledge of design control principles and quality engineering techniques throughout the product development process.
• Can provide instruction and guidance of processes and procedures
• defect analysis skills', 'design and implementation of quality testing and validation tools
• development and implementation of processes and procedures
• SaMD

Nice to Have skills:

• 1-3 years of medical/clinical experience or exposure
• 2 years Medical Device experience
• Agile QMS
• Experience in Cloud Based Software
• NC/CAPA

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com


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