USA - Quality Assurance Engineer II - CTQ
USA - Quality Assurance Engineer II - CTQ
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Location:- Skaneateles NY
Contract Length: 6 months
Core Responsibilities:
- Integrate design procedures templates and guidance documents within an ISO 13485-compliant Quality Management System (QMS)
- Conduct Standard Operating Procedure (SOP) gap assessments for process integration in the Front Line Care division
- Participate in in-depth reviews of procedures with Subject Matter Experts (SMEs) especially those related to corrective actions
- Write update review analyze and revise SOPs work instructions forms and templates
- Coordinate SOP reviews and approvals with cross-functional SMEs
- Monitor and ensure proper SOP implementation
- Report integration status to stakeholders periodically
- Collaborate with various functional groups to produce documentation supporting SOP integration
Required Qualifications:
- Bachelors degree required
- 2-4 years of recent relevant experience
- Medical device industry experience
- Strong knowledge of ISO 13485 (esp. section 7.3) and 21 CFR 820.30
- Proven experience writing and implementing SOPs
- Excellent verbal and written communication skills
- Strong documentation practices and interpersonal skills
- Exceptional problem-solving skills and attention to detail
Nice to Have:
- Knowledge of Agile Product Lifecycle Management Tool
- Familiarity with SAP
Employment Type
Full Time
