Salary:
$50.04 – 75.06 per hour
Reference:
1034557
Job Summary:
A Software Quality Engineer is needed for a multinational pharmaceutical and biotechnology company, whose areas of business include pharmaceuticals, consumer healthcare products, agricultural chemicals, seeds, and biotechnology products. Remote work. This role oversees software quality for medical devices, ensuring compliance with FDA design controls and regulatory standards, conducting evaluations throughout the development lifecycle, and contributing to continuous improvement initiatives.
Location:
Remote, Remote
Job Type:
Contract
Salary:
$50.04 – 75.06 per hour
Work Hours:
8am to 5pm
Education:
Bachelors
Responsibilities:
- Manage Software in Medical Device (SiMD) and Software as a Medical Device (SaMD) for Class-1 and Class-2 medical devices.
- Ensure compliance with regulatory standards such as FDA Design Controls, IEC 62304, IEC 82304, IEC 14971, ISO 13485, EU MDR, and FDA guidance.
- Evaluate software engineering activities throughout the medical device development lifecycle.
- Review and provide feedback on deliverables of medical device software lifecycle.
- Ensure computer system validation compliance according to standards and guidance.
- Build Quality into all aspects of work by maintaining compliance with quality requirements.
Skills:
- Experience interpreting and applying industry standards for medical device development.
- Ability to handle multiple tasks/projects and manage priorities.
- Technical writing ability.
Education and Experience:
Bachelor’s degree in Computer Engineering, Electronics, or Electrical Engineering.
Minimum of 7 years of relevant work experience in software or quality engineering in medical device development.
Minimum of 2 years of experience in software quality management of Class 2 or Class 3 medical devices.
Qualifications:
Experience level: Experienced
Education: Bachelors
Skills:
- Regulatory Affairs / Compliance
- Medical Device
- Technical Writing
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].
Pay offered to a successful candidate will be based on several factors including the candidate’s education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
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