Senior Software Quality Assurance Engineer
Senior Software Quality Assurance Engineer
Posted on :
24-07-2025
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1 Vacancy
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Job Description
Our customer in the medical device sector is hiring a Senior Software Quality Assurance Engineer for their growing company that develops implantable novel neuromodulation medical devices for the treatment of epilepsy and sleep apnea. and nbsp;This is a fully remote role
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This role actively participates in the development of product and non-product (e.g. automated manufacturing test systems) software and firmware by serving as a core team member. and nbsp;
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Job Functions and nbsp;
- Serves as a core team member on software/firmware product development teams by providing technical leadership and direction. Responsible for the risk management file compliance with design control regulations development of design requirements architecture specifications and design verification/validation (including unit and integration testing). and nbsp;
- Chair the change control board within projects for change requests and defects identified during the course of development. and nbsp;
- Provide valuable technical feedback in code reviews. and nbsp;
- Lead (technical expert) and oversee/approve investigations of software/firmware-related complaints defects identified during development or from manufacturing nonconformities audit responses and CAPAs to identify root cause and corrective actions in a timely manner. and nbsp;
- Generates maintains and updates risk management documentation throughout the life cycle of a product. and nbsp;
- Ensures compliance with software/firmware development and non-product software validation procedures. and nbsp;
- Contributes to successful regulatory audits by coordinating back-room / front-room activities or serving as a subject matter expert. and nbsp;
Knowledge and amp; Skills and nbsp;
- Experience with developing software or firmware in the medical device industry including demonstrated proficiency in meeting the requirements of IEC 62304. and nbsp;
- Develop and maintain strong positive business relationships with key internal customers such as R and amp;D Clinical Regulatory Affairs and Operations to fulfill design development activities support audits/inspections and develop and implement plans that will ensure company compliance with regulatory requirements. and nbsp;
- Collaborate with other areas within Quality to achieve quality objectives. and nbsp;
- Exhibit strong leadership skills showing the ability to influence both peers and other team members. and nbsp;
- Exhibit Excellent written and verbal communication skills. and nbsp;
- Demonstrate an ability to prioritize and plan activities. and nbsp;
- Possesses in-depth knowledge of pertinent regulations (E.G. ISOCFR Part 820 etc.) to assure the documentation of all company-wide functions meets these requirements and when necessary identify compliant effective and efficient approaches to fulfilling such requirements. (Note: This is not a Software Test Engineer role.)
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Qualifications
Education and nbsp;
- BS in Computer Engineering Computer Science Electrical Engineering (with education/experience in software development) preferred or other related degree. Advanced Degree or professional certifications are valued.
- Experience with implantable medical devices is a major plus.
- Requirements and nbsp;
- 6 years of experience and nbsp;
- Sustained record of performance during tenure in previous position. and nbsp;
- Has full accountability for representing Quality Engineering on project teams. and nbsp;
- Ability to present procedural requirements and design deliverables clearly during audits and regulatory inspections.
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Sponsorship: Is and nbsp;NOT and nbsp;available for this position
Compensation: $110000 - $140000 DOE plus benefits
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Applicants must be authorized to work for any U.S. employer.
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Staff Smart Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex pregnancy sexual orientation gender identity national origin age protected veteran status genetic information disability status or any other characteristic protected by law.
Employment Type
Full Time
Key Skills
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