Sr. Quality Engineer

Shalby Advanced Technologies Inc•El Dorado Hills, CA

1d•$95,000 - $110,000•Onsite

About The Position

Shalby Advanced Technologies has a new opening for an on-site Sr. Quality Engineer. The Sr. Quality Engineer will have the responsibility of both internal and external (i.e. supplier) aspects of Quality. DUTIES/RESPONSIBILITIES The Sr. Quality Engineer is responsible for performance of the following quality system functions in accordance with documented procedures: Internal Quality Facilitating Corrective Action or Preventive Action (CAPA) process by initiating CAPA, collaborating with cross-functional teams for Root Cause Analysis (RCA) and driving timely completion of corrective or preventive action, performing verification of effectiveness, assuring required approvals and CAPA closure are performed. Facilitating complaint handling by determining if a reported incident is a complaint, initiating complaint report, collaborating with cross-functional teams for action plan and driving timely completion of action plan, assuring required approvals and complaint closure are performed. Facilitating Medical Device Reporting for reportable complaints using eSubmitter to complete Medwatch Reports and submitting to the FDA using Webtrader electronic submissions gateway. Supporting Management Review process by compiling information for management reviews, generating reports, making presentations for assigned quality metrics, taking minutes (as required), assuring minutes are prepared, approved, and routed to executive management and meeting participants. Supporting New Product Development and design or manufacturing changes for company’s existing products. Participating in Material Review Board (MRB) for appropriate disposition of non-conforming materials or products. Supplier Quality Leading supplier qualification to ensure supplier meets SAT’s standards. Co-ordinating supplier change activities between suppliers and internal stakeholders and completing any necessary documentation. Monitoring supplier performance and taking any necessary actions in case supplier’s performance does not meet thresholds established by SAT. Assigning Supplier Corrective Action Request (SCAR) to address a quality issue or non-conformance in materials or products and working with supplier for its timely closure. Planning, conducting, and reporting on supplier audits, ensuring compliance with ISO 13485, FDA QMSR, and other regulations.

Requirements

Bachelor’s degree in engineering or technical discipline
6+ years’ experience in medical device industry, preferably orthopedics
Familiarity with 21 CFR 820 and ISO 13485 requirements
Working knowledge of CAPA, Complaint Handling, MDR Reporting, and Management Review processes
Proficient in machining methodologies, knowledge of hardness, passivation, surface treatments, cleaning techniques etc. for communication with suppliers and engineers
Process Validation experience
Exposure to regulatory agency inspections (e.g., FDA, certification/notified bodies, etc.) and supplier audits, preferably ISO 13485
Technical writing skills that include Quality Management Systems (QMS) and procedures
Proven ability to work cross-functionally to achieve business outcomes
Ability to travel (~25%). Travel shall mainly be for supplier on-site audits and/or trouble shooting
Computer skills (MS Word, Excel, PowerPoint, Access, etc.)

Responsibilities

Facilitating Corrective Action or Preventive Action (CAPA) process by initiating CAPA, collaborating with cross-functional teams for Root Cause Analysis (RCA) and driving timely completion of corrective or preventive action, performing verification of effectiveness, assuring required approvals and CAPA closure are performed.
Facilitating complaint handling by determining if a reported incident is a complaint, initiating complaint report, collaborating with cross-functional teams for action plan and driving timely completion of action plan, assuring required approvals and complaint closure are performed.
Facilitating Medical Device Reporting for reportable complaints using eSubmitter to complete Medwatch Reports and submitting to the FDA using Webtrader electronic submissions gateway.
Supporting Management Review process by compiling information for management reviews, generating reports, making presentations for assigned quality metrics, taking minutes (as required), assuring minutes are prepared, approved, and routed to executive management and meeting participants.
Supporting New Product Development and design or manufacturing changes for company’s existing products.
Participating in Material Review Board (MRB) for appropriate disposition of non-conforming materials or products.
Leading supplier qualification to ensure supplier meets SAT’s standards.
Co-ordinating supplier change activities between suppliers and internal stakeholders and completing any necessary documentation.
Monitoring supplier performance and taking any necessary actions in case supplier’s performance does not meet thresholds established by SAT.
Assigning Supplier Corrective Action Request (SCAR) to address a quality issue or non-conformance in materials or products and working with supplier for its timely closure.
Planning, conducting, and reporting on supplier audits, ensuring compliance with ISO 13485, FDA QMSR, and other regulations.