Engineer, Quality
$70,000–$70,000 year
On-siteBuffalo, New York, United States
Job Summary
Support and maintain the Quality Management System (QMS) to ensure compliance with FDA, ISO 13485, CMDR, and TGA requirements. Participate in design control activities, CAPA investigations with root cause analysis, and risk management per ISO 14971. Conduct intake and resolution of customer complaints while supporting validation activities, internal and external audits, and change controls. Collaborate cross-functionally with R&D, Manufacturing, and Regulatory Affairs to address quality issues and improve processes. Provide guidance and training on quality standards and analyze metrics to drive continuous improvement.
Required Qualifications
- Bachelor's Degree in Engineering, Life Sciences or related field
- 3-5+ years' experience in Quality in GMP environment
- Working knowledge of current FDA, ISO 13485, CMDR and TGA medical device regulations
- Ability to respond to internal and external quality audits and perform root cause analysis and risk assessment activities
- Proficiency with Microsoft Office software (e.g. Microsoft Word, PowerPoint, Excel)
- Excellent technical writing and organizational skills
- Familiarity with design controls and product lifecycle management
- Strong analytical, problem-solving, and communication skills, both written and verbal, to clearly and concisely communicate to all levels of the organization
- Strong work ethic and an ability to excel within a rapidly changing and growing organization
- Thrives in a fast-paced, collaborative environment, efficiently works under pressure, within deadlines or other time essential constraints
Desired Qualifications
- ASQ Certified Quality Engineer (CQE) or similar certification
- Experience with regulatory submissions (510(k), CE Marking)
- Experience with eQMS systems (e.g., MasterControl)
- Experience with risk management (ISO 14971) and validation activities
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