Lead the development of process risk management per ISO14971 for assigned projects
Job Summary
Lead the development of process risk management per ISO14971 for assigned projects.
Participates in and leads assigned project teams/tasks for the development and support of new and sustaining products and processes by providing quality engineering services to assigned projects with accountability for development, execution, and reporting of assigned activities for test method validation, design and process verification and validation, etc.
Facilitates audit functions to support audits by governmental competent authorities (e.g., US Food and Drug Administration (FDA) inspections), Notified Body audits, and internal/corporate audits; May participate in audits as a Technical subject matter expert.
Matching Summary
Lead the development of process risk management per ISO14971 for assigned projects.
Salary
$106,000 - $145,750
Skills & Requirements
Must-have
Process risk management per ISO14971
Failure investigations and problem resolution
Test method validation
Design and process verification and validation
Reviewing drawings for quality requirements
Nice-to-have
Collaborate with innovative people
Empathy and clinical intelligence
Mentoring lower-level engineers
Key Requirements
3 years of experience as a Quality Engineer
Medical device company experience
Root cause investigations on medical device, bio-technology, and pharma products
Reviewing and approving process validation reports
Reviewing and approving updates to quality system or design history documents and labeling
United States Food and Drug Administration (FDA) regulations knowledge