Staff Engineer, Software Design Assurance, Medical Device
Abbott
CloudCyber Security
Job Level
Mid-LevelSenior
About the role
- Conduct audits of suppliers, affiliates, and manufacturing sites to ensure compliance with government regulations, international standards (e.g., ISO 13485, MDSAP), and company policies
- Document audit findings in comprehensive reports for management review
- Lead audit teams, including technical experts and auditors-in-training
- Maintain audit records and manage re-audit documentation
- Mentor and guide junior auditors and volunteers
- Contribute to the development of audit procedures and best practices
- Stay current with regulatory changes through industry engagement
- Adhere to company guidelines for travel, health, safety, and environmental practices
Requirements
- Bachelor’s degree in a related science or engineering field, or equivalent experience
- Proven experience conducting and managing audits, with expertise in ISO 13485 and MDSAP
- Strong understanding of FDA CFR Part 820 and ISO 13485 regulations
- Proficiency in quality management principles, auditing techniques, and statistical analysis
- Ability to lead audit teams and communicate effectively with regulatory bodies and internal stakeholders
- Skilled in Microsoft Office and comfortable interfacing with independent auditors
- ISO Lead Auditor or ASQ Certified Quality Auditor (CQA) certification preferred
- Willingness to travel up to 50% of the time
