Mgr Quality Operations

Job summary:

Leads specified Quality Team supervising execution of key quality processes at the manufacturing facility. The Quality Operations Manager will play an integral role in ensuring the ability to produce a high-quality product, processes are aligned with regulations and standards which are aligned efficiently and compliantly with policies and procedures, and owning the ongoing continuous improvement, maintenance, execution, of QMS area(s) of responsibility.  This role has responsibility for Product Quality support through key phases of production to ensure we meet customer expectations of the highest quality product conforming to all required regulations.

Essential duties:

• Oversee Quality Engineers, Quality Supervisors and Supplier Quality Engineer through final Quality Control and release, with other Operations Quality functions as required. 
• Operations Quality areas of ownership, management, and responsibility may include (as assigned):  QC in-process testing, Product Quality and Continuous Improvement, Production and Process Controls, Non-conformance investigation and controls, Product Release, Supplier management, etc.
• Understand & Support medical device and disposables manufacturing; demonstrated ability to improve product and process quality through the use of quality management techniques, such as LEAN Six Sigma, First Time Quality (FTQ) / Poka-Yoke initiatives; identify and drive improvement Kaizen projects to either gain efficiency, improve product quality or cost down.
• Oversee and Lead Non-conformance (NC) process and root cause investigation.  Work with cross functional team to drive improvements to systemically reduce causes of NCs or other forms of variation.
• Oversee and manage the throughput and backlog of inventory and final inspections, and staff/schedule accordingly.
• Partner with Global Supplier Quality function to monitor and manage quality across supply chain to ensure high quality production for either new product development or older products.
• Monitors the Product Quality & Compliance health of the areas(s) within their area of responsibility, and provides metrics to management as required, including any governing oversight boards.
• Identifies and implements continuous improvement opportunities within their area(s) of responsibility.
• Serves as Subject Matter Expert and Process Owner for their area(s) of responsibility during audits and inspections.
• Influences the organization in quality objectives, prioritization and resourcing decisions as necessary

  Education:

• Bachelor’s degree in engineering or a Scientific field and experience sufficient to successfully perform the essential functions of the job may be considered.

•  

  Licenses or certifications:

• AQL Certification, formal LEAN manufacturing training and/or Six Sigma desired.

•  

  Experience:

• Minimum 7-10 years’ experience.
• Preferred minimum 6 years’ experience in Quality Assurance with a heavy emphasis on factory operations, QC testing, product release and nonconformance management.
• Minimum 4 years supervisory experience.
• Preferred training in FDA Quality System Regulation and ISO 13485.
• Experienced in assembly of medical devices.
• Prior experience in manufacturing/operations quality role with leading and overseeing group of engineers.
• Excellent leadership skills, ability to identify and hire talent to support the business needs.
• Good communication and presentation skills.

Job summary:

Leads specified Quality Team supervising execution of key quality processes at the manufacturing facility. The Quality Operations Manager will play an integral role in ensuring the ability to produce a high-quality product, processes are aligned with regulations and standards which are aligned efficiently and compliantly with policies and procedures, and owning the ongoing continuous improvement, maintenance, execution, of QMS area(s) of responsibility.  This role has responsibility for Product Quality support through key phases of production to ensure we meet customer expectations of the highest quality product conforming to all required regulations.

Essential duties:

• Oversee Quality Engineers, Quality Supervisors and Supplier Quality Engineer through final Quality Control and release, with other Operations Quality functions as required. 
• Operations Quality areas of ownership, management, and responsibility may include (as assigned):  QC in-process testing, Product Quality and Continuous Improvement, Production and Process Controls, Non-conformance investigation and controls, Product Release, Supplier management, etc.
• Understand & Support medical device and disposables manufacturing; demonstrated ability to improve product and process quality through the use of quality management techniques, such as LEAN Six Sigma, First Time Quality (FTQ) / Poka-Yoke initiatives; identify and drive improvement Kaizen projects to either gain efficiency, improve product quality or cost down.
• Oversee and Lead Non-conformance (NC) process and root cause investigation.  Work with cross functional team to drive improvements to systemically reduce causes of NCs or other forms of variation.
• Oversee and manage the throughput and backlog of inventory and final inspections, and staff/schedule accordingly.
• Partner with Global Supplier Quality function to monitor and manage quality across supply chain to ensure high quality production for either new product development or older products.
• Monitors the Product Quality & Compliance health of the areas(s) within their area of responsibility, and provides metrics to management as required, including any governing oversight boards.
• Identifies and implements continuous improvement opportunities within their area(s) of responsibility.
• Serves as Subject Matter Expert and Process Owner for their area(s) of responsibility during audits and inspections.
• Influences the organization in quality objectives, prioritization and resourcing decisions as necessary

  Education:

• Bachelor’s degree in engineering or a Scientific field and experience sufficient to successfully perform the essential functions of the job may be considered.

•  

  Licenses or certifications:

• AQL Certification, formal LEAN manufacturing training and/or Six Sigma desired.

•  

  Experience:

• Minimum 7-10 years’ experience.
• Preferred minimum 6 years’ experience in Quality Assurance with a heavy emphasis on factory operations, QC testing, product release and nonconformance management.
• Minimum 4 years supervisory experience.
• Preferred training in FDA Quality System Regulation and ISO 13485.
• Experienced in assembly of medical devices.
• Prior experience in manufacturing/operations quality role with leading and overseeing group of engineers.
• Excellent leadership skills, ability to identify and hire talent to support the business needs.
• Good communication and presentation skills.

Job summary:

Leads specified Quality Team supervising execution of key quality processes at the manufacturing facility. The Quality Operations Manager will play an integral role in ensuring the ability to produce a high-quality product, processes are aligned with regulations and standards which are aligned efficiently and compliantly with policies and procedures, and owning the ongoing continuous improvement, maintenance, execution, of QMS area(s) of responsibility.  This role has responsibility for Product Quality support through key phases of production to ensure we meet customer expectations of the highest quality product conforming to all required regulations.

Essential duties:

• Oversee Quality Engineers, Quality Supervisors and Supplier Quality Engineer through final Quality Control and release, with other Operations Quality functions as required. 
• Operations Quality areas of ownership, management, and responsibility may include (as assigned):  QC in-process testing, Product Quality and Continuous Improvement, Production and Process Controls, Non-conformance investigation and controls, Product Release, Supplier management, etc.
• Understand & Support medical device and disposables manufacturing; demonstrated ability to improve product and process quality through the use of quality management techniques, such as LEAN Six Sigma, First Time Quality (FTQ) / Poka-Yoke initiatives; identify and drive improvement Kaizen projects to either gain efficiency, improve product quality or cost down.
• Oversee and Lead Non-conformance (NC) process and root cause investigation.  Work with cross functional team to drive improvements to systemically reduce causes of NCs or other forms of variation.
• Oversee and manage the throughput and backlog of inventory and final inspections, and staff/schedule accordingly.
• Partner with Global Supplier Quality function to monitor and manage quality across supply chain to ensure high quality production for either new product development or older products.
• Monitors the Product Quality & Compliance health of the areas(s) within their area of responsibility, and provides metrics to management as required, including any governing oversight boards.
• Identifies and implements continuous improvement opportunities within their area(s) of responsibility.
• Serves as Subject Matter Expert and Process Owner for their area(s) of responsibility during audits and inspections.
• Influences the organization in quality objectives, prioritization and resourcing decisions as necessary

  Education:

• Bachelor’s degree in engineering or a Scientific field and experience sufficient to successfully perform the essential functions of the job may be considered.

•  

  Licenses or certifications:

• AQL Certification, formal LEAN manufacturing training and/or Six Sigma desired.

•  

  Experience:

• Minimum 7-10 years’ experience.
• Preferred minimum 6 years’ experience in Quality Assurance with a heavy emphasis on factory operations, QC testing, product release and nonconformance management.
• Minimum 4 years supervisory experience.
• Preferred training in FDA Quality System Regulation and ISO 13485.
• Experienced in assembly of medical devices.
• Prior experience in manufacturing/operations quality role with leading and overseeing group of engineers.
• Excellent leadership skills, ability to identify and hire talent to support the business needs.
• Good communication and presentation skills.