Quality Engineer Jobs

PURPOSEOFJOB:

SupportRoute92Medical'seffortstosustainabestpracticeQualitySystemby ensuringcompliancetoregulatoryrequirementssuchasFDAQSR,ISO13485andtheEUMDR,andthatproductsmeetallapplicableinternalandexternalrequirements,fromnewproductconception, development, through productlaunch.

MAJOR DUTIES AND RESPONSIBILITIES:

• Write QMS software validation plans and reports for company QMS Software.
• Participate in or lead the following:

1. Process and product investigations (CAPA, Complaint, NCMR)
2. External standard and regulation gap assessments
3. Internal, external, and supplier audits

• Support the following functions as needed:
• Act as a eQMS System Administrator, Module Administrator, and/or Module Coordinator

1. Design Control projects
2. Risk management team
3. Regulatory Submissions (EU, US)

• Supportallotherqualityfunctionsasrequestedbymanagement.
• Identify and implement Quality Management System improvements.
• Perform project management of quality plans or other projects

REQUIRED EDUCATION:

• B.S. in biomedical engineering or similardiscipline.

Experience:

Required Experience

1. At least 3-4 years of experience as a Quality Engineer.
2. At least 2 years of experience in a medical device regulated environment.
3. Experience with sampling plans and other statistical methodologies.
4. General knowledge of:

• ISO 13485
• ISO 14971 Risk Management
• 21 CFR 820 Quality System Regulation

Bonus Experience

• CQE Certification
• Audit Certification