Supplier Quality Engineer - Senior
Supplier Quality Engineer - Senior
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
Job Title: Senior Specialist Quality Assurance / Senior Engineer Supplier Development Quality
Duration: 06 Months
Location: Pleasanton CA 94588
Pay range: $55$62/hr on W2
Job Description:
- Strong background in Software as a Medical Device (SaMD) and Class II/III medical devices.
- Skilled in supplier management internal audits software tool validation and participation in FDA inspections.
- Proficient in implementing Quality Management Systems (QMS) conducting root cause analysis using CAPA and 5 Why methodologies and maintaining compliance with regulatory standards including cGMPs ISO 13485 ISO 14971 and IEC 62366.
- Extensive experience supporting the development of Design History Files (DHF) and guiding software development teams through SDLC phases.
MAIN RESPONSIBILITIES
Contributes to the development maintenance and improvement of division supplier development quality program policies procedures and forms.
May provide coaching and mentoring for technical team personnel.
Provides guidance and training to Purchasing R&D Manufacturing and Quality engineers in applying program requirements.
Reviews and approves all supplied product drawings and component quality plans.
Manages development of supplied product inspection procedures and first article requirements.
Provides engineering guidance to division Receiving Inspection including statistical analysis measurement techniques Gage R&R studies and inspection procedures.
Assesses supplier capabilities through direct visits technical discussions directed testing and quality system audits.
Proactively communicates quality issues to suppliers as needed through supplier quality system audits supplier corrective action requests and technical discussions.
Participates and provides engineering ownership for all supplied product NonConforming Material Reviews.
Contributes and participates in supplier performance reviews.
Evaluates and develops Supplied Data Agreement partnerships with suppliers.
Applies sound engineering analysis and judgment to reduce the need for inspection in accordance to program policies.
Works with Manufacturing engineering to assess and address purchased product issues.
Apply sound systematic problemsolving methodologies in identifying prioritizing communicating and resolving quality issues
Design and conduct experiments for process optimization and/or improvement
Participate in or lead teams in supporting Supplier Development Quality program requirements (e.g. represent the Supplier Development Quality function as a Core Team Member)
Complies with U.S. Food and Drug Administration (FDA) regulations other regulatory requirements Company policies operating procedures processes and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees customers contractors and vendors.
For any concern or queries feel free to reach me at /
Employment Type
Full Time
