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5 days ago
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Quality Engineer I - (CAPA/ NCR)


Salary band: $10k - $15k
Location: North America, United States, California
Job type: Permanent
Contact: LanceSoft INC
Category: Quality Engineer
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Summary Of The Job:
The Sr. Engineer for CAPA/NCR has the responsibility to help implement, execute, manage, and standardize CAPA and NCR policies, procedures, and standards across business units which they are responsible for in compliance with Global Surgery, CSS ISO, and worldwide Regulatory requirements.

Essential Duties And Responsibilities:
Under limited supervision, general direction, and in accordance with all applicable federal, state and local laws/regulations and Corporate, procedures and guidelines, this position is:
. Responsible to implement, revise, execute, and maintain CAPA and NCR procedures including the Stop Shipment process.
. Responsible for communicating quality and business related issues or opportunities to next management level.
. Responsible to comply with all Federal, State, local and company regulations, policies and procedures including Health, Safety and Environmental compliance.
. Actively participate and engage in CAPA Review Board as well as corporate trending meetings.
. Work on complex investigations and coordinate technical teams to ensure sound experimental design, effective data analysis, identification, implementation, verification and validation of CAPA actions.
. Follow up with action owners on all action items until items are effectively completed and closed.
. Track and provide monthly CAPA, NCR and Stop Shipment Quality Performance Metrics.
. Act as CAPA, NCR and Stop Shipment Subject Mater Expert (SME).
. Provide instruction and training to associates on requirements and best practices for CAPA, NCR and Stop Shipment.
. Where required, provide back room support for internal, third party, and regulatory inspections and audits as an SME for CAPA/NCR.
. Perform administrative duties within the CAPA and NCR software systems.
. Support and participate in cross-functional projects when assigned, facilitate technical innovations to enhance Quality Systems and support business goals, and assist with other Quality System activities as requested by management.
. Identify opportunities to continuously improve CAPA and NCR-related quality systems and processes in alignment with overall quality and business objectives, as well as taking ownership of CAPAs impacting the NCR or CAPA Quality System.
. Performs other duties assigned as needed

Required Education/Training And/Or Experience:
. BS in a Chemistry, Biology, or Engineering discipline with 3 5 years of related CAPA and NCR Management experience. Minimum of 2-3 years' experience in the medical device industry is required.

Required Knowledge, Skills, Abilities And Certifications/Licenses:
. Must possess a clear understanding of theoretical and practical fundamentals and experimental engineering techniques. Good written and oral communication skills. Computer literate.
. Ability to use broad knowledge of regulatory, technical, and business requirements to effectively lead and manage improvement projects for Quality Systems.
. Ability to apply project management skills to measure and improve performance in areas of responsibility.
. Thorough knowledge of CAPA and NCR.
. Demonstrated root cause and problem solving skills.
. Ability to apply Six Sigma and Process Excellence tools and methodologies preferred.
. Demonstrated verbal and written communication skills, and ability to effectively communicate with internal and external personnel.
. Ability to effectively train, and influence a diverse array of employees impacted by Quality Systems initiatives and performance measurements.
. Proficiency with quality-related applications such as those for Minitab, Statgraphics, QI Macros, etc would be a plus.
. Hands on experience with Risk Assessment (especially Hazard Analysis, Fault Tree Analysis, SHUMA, DFMEA, FMEA, FMECA, PFMEA), Reliability Engineering and/or Product/Process Validation are preferred.
. Experience with EtQ CAPA, NCR and Audit module would highly desired.
. Business and financial acumen.
Summary Of The Job:
The Sr. Engineer for CAPA/NCR has the responsibility to help implement, execute, manage, and standardize CAPA and NCR policies, procedures, and standards across business units which they are responsible for in compliance with Global Surgery, CSS ISO, and worldwide Regulatory requirements.

Essential Duties And Responsibilities:
Under limited supervision, general direction, and in accordance with all applicable federal, state and local laws/regulations and Corporate, procedures and guidelines, this position is:
. Responsible to implement, revise, execute, and maintain CAPA and NCR procedures including the Stop Shipment process.
. Responsible for communicating quality and business related issues or opportunities to next management level.
. Responsible to comply with all Federal, State, local and company regulations, policies and procedures including Health, Safety and Environmental compliance.
. Actively participate and engage in CAPA Review Board as well as corporate trending meetings.
. Work on complex investigations and coordinate technical teams to ensure sound experimental design, effective data analysis, identification, implementation, verification and validation of CAPA actions.
. Follow up with action owners on all action items until items are effectively completed and closed.
. Track and provide monthly CAPA, NCR and Stop Shipment Quality Performance Metrics.
. Act as CAPA, NCR and Stop Shipment Subject Mater Expert (SME).
. Provide instruction and training to associates on requirements and best practices for CAPA, NCR and Stop Shipment.
. Where required, provide back room support for internal, third party, and regulatory inspections and audits as an SME for CAPA/NCR.
. Perform administrative duties within the CAPA and NCR software systems.
. Support and participate in cross-functional projects when assigned, facilitate technical innovations to enhance Quality Systems and support business goals, and assist with other Quality System activities as requested by management.
. Identify opportunities to continuously improve CAPA and NCR-related quality systems and processes in alignment with overall quality and business objectives, as well as taking ownership of CAPAs impacting the NCR or CAPA Quality System.
. Performs other duties assigned as needed

Required Education/Training And/Or Experience:
. BS in a Chemistry, Biology, or Engineering discipline with 3 5 years of related CAPA and NCR Management experience. Minimum of 2-3 years' experience in the medical device industry is required.

Required Knowledge, Skills, Abilities And Certifications/Licenses:
. Must possess a clear understanding of theoretical and practical fundamentals and experimental engineering techniques. Good written and oral communication skills. Computer literate.
. Ability to use broad knowledge of regulatory, technical, and business requirements to effectively lead and manage improvement projects for Quality Systems.
. Ability to apply project management skills to measure and improve performance in areas of responsibility.
. Thorough knowledge of CAPA and NCR.
. Demonstrated root cause and problem solving skills.
. Ability to apply Six Sigma and Process Excellence tools and methodologies preferred.
. Demonstrated verbal and written communication skills, and ability to effectively communicate with internal and external personnel.
. Ability to effectively train, and influence a diverse array of employees impacted by Quality Systems initiatives and performance measurements.
. Proficiency with quality-related applications such as those for Minitab, Statgraphics, QI Macros, etc would be a plus.
. Hands on experience with Risk Assessment (especially Hazard Analysis, Fault Tree Analysis, SHUMA, DFMEA, FMEA, FMECA, PFMEA), Reliability Engineering and/or Product/Process Validation are preferred.
. Experience with EtQ CAPA, NCR and Audit module would highly desired.
. Business and financial acumen.

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