Quality Engineer IV
An ideal candidate for this role is someone who can thoroughly assess potential product risks and summarize them in a clear, concise manner; a natural ability to categorize information and see possibilities beyond the obvious would be helpful.
Successful candidates will have the following types of experience:
This role is part of the team that manages post-market medical device risk. As such, it is mandatory to have hands-on experience executing medical device risk management in alignment with ISO 14971 and QSR. Primary responsibilities of this position include aggregating and presenting periodic risk data, generating risk management reports, collaborating with technical experts to update risk documents (e.g., FMEAs), and assessing hazards.
• Evaluate risk. Aggregate and analyze data from multiple sources (e.g., signal detection, medical review, etc.) and identify common trends.
• Escalate risk. Use sound judgment to identify novel events and new risks, then make recommendations to escalate or provide rationale regarding why escalation is not necessary.
• Champion collaboration. Actively engage with product engineers and medical officers across the organization to ensure evaluation of product risk considers multiple inputs.
• Bachelor’s degree or higher in an engineering or scientific discipline
• Experience in the medical devices sector:
• Bachelor’s: 5 years
• Master’s: 3 years
• Doctorate: 2 years
• 1-2 years of dedicated experience with product risk per ISO 14971
• Ability to interpret basic statistical data and graphs
• Experience following the requirements of ISO 13485 and QSR, including NCR and CAPA
• Excellent writing and presentation skills
• A critical eye for detail
• Ability to work cross-functionally
• Project management experience
• CQE or risk management certification
• Experience interacting with regulatory agencies
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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