Software Quality Engineer

Quality Engineer – Software Validation *Location:* Hybrid, 4 Days Onsite *Duration:* 6+ Month Contract-to-Hire *Pay Rate:* $45-$55/hour *Position Overview* We are seeking a Quality Engineer II to support medical device software development and commercially available software products in a regulated healthcare environment. This role will work closely with Quality, R&D, and cross-functional teams to ensure compliance with software development processes, validation requirements, and regulatory standards. The ideal candidate will have experience supporting software quality and validation activities throughout the product lifecycle, with a strong understanding of medical device regulations, design controls, and software verification and validation. *Key Responsibilities* * Support software quality activities for medical device and cloud-based software products * Partner with R&D and Quality teams to implement and maintain quality processes and procedures * Participate in software verification and validation (V&V) activities * Support design quality engineering efforts throughout product development * Ensure compliance with IEC 62304, ISO 13485, EU MDR, and internal quality management systems * Assist with change control activities for medical device software products * Review and maintain software development documentation and quality records * Support risk management, testing, validation, and regulatory compliance initiatives * Contribute to continuous improvement of quality systems and development processes * Participate in Agile development activities and cross-functional project meetings *Required Qualifications* * Bachelor's Degree in a STEM discipline * 2+ years of Quality Engineering, Design Quality, Software Quality, or Validation experience * Experience with Computer System Validation (CSV) or Software Validation * Knowledge of medical device software development processes * Experience with Quality Management Systems (QMS) * Understanding of software verification and validation methodologies * Experience supporting regulated product development environments * Familiarity with change control processes for medical device products * Strong communication and cross-functional collaboration skills *Preferred Qualifications* * Experience with: * IEC 62304 * ISO 13485 * EU MDR * Medical device industry experience * Cloud-based software support experience * Agile development experience * Knowledge of design control requirements * Regulatory and compliance experience * Experience with quality testing and validation tools *Desired Skills* * Design Quality Engineering * Software V&V * Computer System Validation * Quality Systems * Regulatory Compliance * Product Development * Risk Management * Change Control * Cloud Technologies * Agile Methodologies _Equal Opportunity Employer/Veterans/Disabled_ _Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client_ _To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/_ _The Company will consider qualified applicants with arrest and conviction records. _ #GRPB Pay: $45.00 - $55.00 per hour Expected hours: No less than 40.0 per week Benefits: * 401(k) * Dental insurance * Health insurance * Life insurance * Vision insurance People with a criminal record are encouraged to apply Work Location: Hybrid remote in Denver, CO 80281