Description

You will provide Quality Assurance and Engineering support for software product development, IT implementation, and process improvement projects within digital solutions.

Responsibilities

• Execute quality assurance and process management activities for new digital products and software management processes.
• Lead quality system activities including change control, validation, design control, NC, CAPA, and risk management.
• Execute IT systems validation programs and ensure adherence to industry best practices and validation methodologies.
• Apply quality engineering techniques such as risk analysis, test method development, design of experiments, and statistical data analysis.
• Manage product lifecycle deliverables to ensure they meet regulatory requirements and pass internal and external audits.

Required Skills

• 3-5 years of experience in IT and Quality within a regulated medical device environment.
• 2-3 years of experience in software management or IT environments subject to FDA or other government regulations.
• 2-3 years of hands-on experience in software validation and managing validation strategies.
• 1+ years of experience in Quality, Regulatory, or Compliance roles with exposure to risk-based compliance.
• 1+ years of experience working within agile development methodologies.
• In-depth knowledge of FDA regulations (21 CFR 820, cGxP, 21 CFR Part 11), EU MDR, and ISO standards (9001, 13485, 14971, 27001).
• Working knowledge of IEC 62304, HIPAA, and GDPR.
• Ability to work remotely on Eastern Time hours using your own equipment.

Preferred Skills

• Certifications in Quality such as CSQE or CQM.
• Certifications in project, change, or process management such as Lean, Six Sigma, PMB, or CMMi.
• Certification in Auditing.

Key Skills

Education

Any Graduate