Quality Auditor/specialist

4 weeks ago

Scottsdale, United States Surgenex Full time

**Job description**

**About Us**: SURGENEX® is a privately held biotechnology company and accredited Tissue Bank by the AATB. Our company is headquartered in Scottsdale, Arizona. We develop, manufacture, and distribute the highest quality tissue allograft in the industry to accounts within the United States.

***

This position is responsible for monitoring and analyzing current and impending regulations and standards,conducting, and facilitating internal and external audits. The Quality Specialist (QS) will assist with the development and implementation of Corrective and Preventive action (CAPA) plans and conducting Verification of Effectiveness (VOE) Checks. Assists with ensuring compliance to state, federal, local, international, and accrediting agency regulations and standards as well as Surgenex standard operating procedures (SOPs). This position is also responsible for technical development of personnel, leading others through audits, ensuring audit deliverables, and maintaining the quality management system documentation.

**KEY RESPONSIBILITIES**
- Execute and monitor all Surgenex processes and activities to ensure compliance and product quality.
- Participate in the creation, implementation, and monitoring of processes to ensure product specifications are met.
- Responsible for conducting internal audits per the established audit schedule to ensure Surgenex’s compliance to all Surgenex procedures, federal, state, local and international regulations and accrediting agency standards and assisting with conducting and facilitating external audits.
- Identify processes for audit, to include:

- those required by regulatory bodies or accrediting agencies.
- processes having undergone significant revision.
- effectiveness assessments of corrective and preventive action plans.
- those processes with a significant number of failure points.
- Surgenex regulatory and accrediting agency audit CAPA responses.
- Observe, review, and analyze processes to ensure quality standards are upheld throughout the organization at all times.
- Ensures audits (self-assessments) required by accrediting bodies are completed within prescribed time frames.
- Conducts audits in accordance to established SOPs ensuring:

- Audits are scheduled, conducted, and documented within the quality management system audit program including the initiation of a nonconformance report (NCR) for all audit findings.
- Use of audit assessment checklists which will assess compliance of written policy against regulation and current practice against written procedures.
- Audit reports are written and provided to Surgenex Leadership
- Timely receipt and closure of NCR/CAPA responses
- Verification of effectiveness is performed to ensure ongoing compliance with the implemented CAPAs
- Serves as a resource for the development of corrective actions to address observations and findings.
- Assist the DRA with preparing for and facilitating external audits in accordance to established procedures.
- Audits are initiated, conducted, and documented within the quality management system audit program including the initiation of NCR’s for all audit findings.
- Assist with the development and completion of regulatory and accrediting agency gap assessment tools
- Meet with respective department management and staff to collaboratively complete gap assessments
- Assist with addressing all gaps identified to ensure Surgenex establishes compliance
- Responsible for monitoring and analyzing changes in regulatory and accreditation standards that impact operations including but not limited to those of FDA and AATB.
- Qualify and monitor suppliers and service providers.
- Will recommend actions for vendors or suppliers that do not maintain compliance requirements or have a high complaint and/or NCR rate.
- Responsible for assisting the DRA with maintaining the supplier program in the quality management system, ensuring all vendors are documented, accurately categorized, and all relevant documentation (qualification surveys, licenses, registrations, etc.) is attached.
- Track and trend audit findings to assist departmental management in identifying opportunities for improvement (OFIs).
- Serve as a resource to departmental management in reviewing proposed revisions to policies, procedures, and forms to determine regulatory compliance prior to implementation.
- Performs other duties as assigned.

**POSITION QUALIFICATIONS**
- Accuracy - Ability to perform work accurately and thoroughly.
- Accountability - Ability to accept responsibility and account for his/her actions.
- Active Listening - Ability to actively attend to, convey, and understand the comments and questions of others.
- Conflict Resolution - Ability to deal with others in an antagonistic situation.
- Customer Oriented - Ability to take care of the customers’ needs while following company procedures.
- Detail Oriented - Ability to pay attention to the minute details of a project or task.
- Honesty / Integr

  • Quality Auditor Specialist

    2 weeks ago

    Scottsdale, United States Surgenex Full time

    POSITION SUMMARYThis position is responsible for monitoring and analyzing current and impending regulations and standards,conducting, and facilitating internal and external audits. The Quality Specialist (QS) will assist with the development and implementation of Corrective and Preventive action (CAPA) plans and conducting Verification of Effectiveness (VOE)...

  • Quality Auditor Specialist

    3 days ago

    Scottsdale, United States Surgenex Full time

    POSITION SUMMARYThis position is responsible for monitoring and analyzing current and impending regulations and standards,conducting, and facilitating internal and external audits. The Quality Specialist (QS) will assist with the development and implementation of Corrective and Preventive action (CAPA) plans and conducting Verification of Effectiveness (VOE)...

  • Quality Auditor Specialist

    1 week ago

    Scottsdale, United States Surgenex Full time

    POSITION SUMMARYThis position is responsible for monitoring and analyzing current and impending regulations and standards,conducting, and facilitating internal and external audits. The Quality Specialist (QS) will assist with the development and implementation of Corrective and Preventive action (CAPA) plans and conducting Verification of Effectiveness (VOE)...

  • Quality Auditor Specialist

    2 weeks ago

    Scottsdale, United States Surgenex Full time

    POSITION SUMMARYThis position is responsible for monitoring and analyzing current and impending regulations and standards,conducting, and facilitating internal and external audits. The Quality Specialist (QS) will assist with the development and implementation of Corrective and Preventive action (CAPA) plans and conducting Verification of Effectiveness (VOE)...

  • Quality Auditor Specialist

    1 week ago

    Scottsdale, United States Surgenex Full time

    POSITION SUMMARYThis position is responsible for monitoring and analyzing current and impending regulations and standards,conducting, and facilitating internal and external audits. The Quality Specialist (QS) will assist with the development and implementation of Corrective and Preventive action (CAPA) plans and conducting Verification of Effectiveness (VOE)...

  • Quality Auditor Specialist

    2 weeks ago

    Scottsdale, United States Surgenex Full time

    **About Us**:SURGENEX® is a privately held biotechnology company and accredited Tissue Bank by the AATB. Our company is headquartered in Scottsdale, Arizona. We develop, manufacture, and distribute the highest quality tissue allograft in the industry to accounts within the United States. **Position Summary**: This position is responsible for monitoring and...

  • Internal Auditor and Senior Internal Auditor

    3 weeks ago

    Scottsdale, United States Veridian National Search Full time

    Internal Auditor and Senior Internal Auditor $8B+ Metals Company - 100% Remote - $60-90K, $80-100K, no bonus The Sizzle: Roles are 100% remote with 20% travel - potentially a monthly visit to an office (if any) Targeting 1-4 years of experience - internal/external audit or accounting/finance Is a self-starter, not afraid to ask questions. Has good knowledge...

  • Internal Auditor and Senior Internal Auditor

    3 weeks ago

    Scottsdale, United States Veridian National Search Full time

    Internal Auditor and Senior Internal Auditor $8B+ Metals Company - 100% Remote - $60-90K, $80-100K, no bonus The Sizzle:Roles are 100% remote with 20% travel - potentially a monthly visit to an office (if any) Targeting 1-4 years of experience - internal/external audit or accounting/finance Is a self-starter, not afraid to ask questions. Has good knowledge...

  • Senior Internal Auditor

    4 weeks ago

    Scottsdale, United States ON Semiconductor Full time

    Description - Internal onsemi (Nasdaq: ON) is driving disruptive innovations to help build a better future. Focused on automotive and industrial end-markets, the company is accelerating change in megatrends such as vehicle electrification and safety, sustainable energy grids, industrial automation, and 5G and cloud infrastructure. With a highly...

  • Senior Internal Auditor

    3 weeks ago

    Scottsdale, United States Onsemi Full time

    Description – Internal onsemi (Nasdaq: ON) is driving disruptive innovations to help build a better future. Focused on automotive and industrial end-markets, the company is accelerating change in megatrends such as vehicle electrification and safety, sustainable energy grids, industrial automation, and 5G and cloud infrastructure. With a highly...

  • Senior Internal Auditor

    1 month ago

    Scottsdale, United States Semiconductor Components Industries, LLC Full time

    Description – External onsemi (Nasdaq: ON) is driving disruptive innovations to help build a better future. Focused on automotive and industrial end-markets, the company is accelerating change in megatrends such as vehicle electrification and safety, sustainable energy grids, industrial automation, and 5G and cloud infrastructure. With a highly...

  • Internal Auditor II- REMOTE

    3 weeks ago

    Scottsdale, United States La-Z-Boy Full time

    Comfort starts with our 13,000+ team members across the globe, who are transforming the power of comfort every day. Our employees have the power to change lives, in our homes, work and communities. We foster an inclusive environment while honoring a legacy built on family, where everyone can be themselves. If you are ready to join an industry leading...

  • Internal Auditor II- REMOTE

    2 weeks ago

    Scottsdale, United States La-Z-Boy Full time

    Comfort starts with our 13,000+ team members across the globe, who are transforming the power of comfort every day. Our employees have the power to change lives, in our homes, work and communities. We foster an inclusive environment while honoring a legacy built on family, where everyone can be themselves. If you are ready to join an industry leading...

  • Internal Auditor II- REMOTE

    1 week ago

    Scottsdale, United States La-Z-Boy Full time

    Comfort starts with our 13,000+ team members across the globe, who are transforming the power of comfort every day. Our employees have the power to change lives, in our homes, work and communities. We foster an inclusive environment while honoring a legacy built on family, where everyone can be themselves. If you are ready to join an industry leading...

  • Air Quality Specialist

    1 week ago

    Scottsdale, United States Canacre Full time

    Job DescriptionJob DescriptionJoin the Canacre team in an exciting role working on leading edge infrastructure projects.We are technical experts in land, energy, and transportation development delivering accurate, innovative, and agile solutions to our partners. We provide land acquisition, geospatial mapping, data management, web-based GIS, community...

  • Air Quality Specialist

    2 months ago

    Scottsdale, United States Canacre Full time

    Job DescriptionJob DescriptionJoin the Canacre team in an exciting role working on leading edge infrastructure projects.We are technical experts in land, energy, and transportation development delivering accurate, innovative, and agile solutions to our partners. We provide land acquisition, geospatial mapping, data management, web-based GIS, community...

  • Quality Control Specialist

    2 weeks ago

    Scottsdale, United States Surgenex Full time

    SURGENEX® is a privately held biotechnology company. Our company is headquartered in Scottsdale, Arizona. We develop, manufacture, and distribute the highest quality tissue allograft in the industry to accounts within the United States. - Execute key quality functions in support of product flow in production, logistics, and distribution. - Perform document...

  • Quality Assurance Manager

    3 weeks ago

    Scottsdale, United States QISG Full time

    General Description The QA/QC Manager is responsible for monitoring and auditing a project's quality management requirements, as well as the execution of the project Quality Management Plan. This position will work closely with Project Managers and Construction Managers for the monitoring and oversight of project quality objectives/activities. The QA/QC...

  • Quality Assurance Manager

    2 weeks ago

    Scottsdale, United States QISG Full time

    Job DescriptionJob DescriptionGeneral DescriptionThe QA/QC Manager is responsible for monitoring and auditing a project’s quality management requirements, as well as the execution of the project Quality Management Plan. This position will work closely with Project Managers and Construction Managers for the monitoring and oversight of project quality...

  • Quality Assurance Manager

    1 week ago

    Scottsdale, United States QISG Full time

    Job DescriptionJob DescriptionGeneral DescriptionThe QA/QC Manager is responsible for monitoring and auditing a project’s quality management requirements, as well as the execution of the project Quality Management Plan. This position will work closely with Project Managers and Construction Managers for the monitoring and oversight of project quality...