Technical Services Quality Manager

Job summary:

Leads specified Technical Quality Management Systems team supervising detailed work on a specific portion of a broader task assigned to experienced quality specialists. The Technical Quality Manager will play an integral role in interpreting regulations and standards into Terumo BCT policies and procedures, and owning the ongoing maintenance, execution, and improvement of their QMS area(s) of responsibility.  Support and improve various Quality System processes to maintain regulatory compliance.

Essential duties:

• Technical Quality Manager areas of ownership, management, and responsibility may include (as assigned): Calibrations, Validation Process, Microbiology Lab, Receiving and Supplier Management.
• Serves as expert and main point of contact for regulatory / compliance issues within area of responsibility.
• Acts as the policy / procedure owner for area(s) of responsibility, ensuring they are compliant and effective. 
• Executes their QMS area(s) in accordance with governing internal policies / procedures and external standards and regulations.  This likely includes generation and approval of annual schedules, execution to schedule, approval of plans or reports, follow up on action items, facilitation of discussion s with participants and stakeholders to ensure success and compliance.
• Monitors the health of the QMS 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 QMS area(s) of responsibility during audits and inspections.
• Influences the organization in quality objectives, prioritization, and resourcing decisions as necessary.
• Manages team of direct reports in support of the above (as applicable).
• Manages and provides operational leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
• Acts as an internal champion for quality initiatives aimed at improving business systems and compliance; may be the primary representative of Quality group on projects.
• During audits and inspections, interfaces with global regulatory authority, notified body auditors and provides general support for the Quality group.
• Interfaces with QMS area owners and project teams from other Terumo BCT locations, regions, and corporate.

Education:

• Bachelor’s degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

Licenses or certifications:

• N/A.

Experience:

• Minimum 5 years’ experience.
• Preferred minimum 7 years’ experience in Quality Assurance and or Regulatory Affairs, involving US FDA Class II or Class III medical devices including knowledge & experience of applying global device laws & regulations for adverse event reporting and product recalls. 
• Minimum 2 years supervisory experience.
• Preferred training in FDA Quality System Regulation and ISO 13485.

Job summary:

Leads specified Technical Quality Management Systems team supervising detailed work on a specific portion of a broader task assigned to experienced quality specialists. The Technical Quality Manager will play an integral role in interpreting regulations and standards into Terumo BCT policies and procedures, and owning the ongoing maintenance, execution, and improvement of their QMS area(s) of responsibility.  Support and improve various Quality System processes to maintain regulatory compliance.

Essential duties:

• Technical Quality Manager areas of ownership, management, and responsibility may include (as assigned): Calibrations, Validation Process, Microbiology Lab, Receiving and Supplier Management.
• Serves as expert and main point of contact for regulatory / compliance issues within area of responsibility.
• Acts as the policy / procedure owner for area(s) of responsibility, ensuring they are compliant and effective. 
• Executes their QMS area(s) in accordance with governing internal policies / procedures and external standards and regulations.  This likely includes generation and approval of annual schedules, execution to schedule, approval of plans or reports, follow up on action items, facilitation of discussion s with participants and stakeholders to ensure success and compliance.
• Monitors the health of the QMS 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 QMS area(s) of responsibility during audits and inspections.
• Influences the organization in quality objectives, prioritization, and resourcing decisions as necessary.
• Manages team of direct reports in support of the above (as applicable).
• Manages and provides operational leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
• Acts as an internal champion for quality initiatives aimed at improving business systems and compliance; may be the primary representative of Quality group on projects.
• During audits and inspections, interfaces with global regulatory authority, notified body auditors and provides general support for the Quality group.
• Interfaces with QMS area owners and project teams from other Terumo BCT locations, regions, and corporate.

Education:

• Bachelor’s degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

Licenses or certifications:

• N/A.

Experience:

• Minimum 5 years’ experience.
• Preferred minimum 7 years’ experience in Quality Assurance and or Regulatory Affairs, involving US FDA Class II or Class III medical devices including knowledge & experience of applying global device laws & regulations for adverse event reporting and product recalls. 
• Minimum 2 years supervisory experience.
• Preferred training in FDA Quality System Regulation and ISO 13485.

Job summary:

Leads specified Technical Quality Management Systems team supervising detailed work on a specific portion of a broader task assigned to experienced quality specialists. The Technical Quality Manager will play an integral role in interpreting regulations and standards into Terumo BCT policies and procedures, and owning the ongoing maintenance, execution, and improvement of their QMS area(s) of responsibility.  Support and improve various Quality System processes to maintain regulatory compliance.

Essential duties:

• Technical Quality Manager areas of ownership, management, and responsibility may include (as assigned): Calibrations, Validation Process, Microbiology Lab, Receiving and Supplier Management.
• Serves as expert and main point of contact for regulatory / compliance issues within area of responsibility.
• Acts as the policy / procedure owner for area(s) of responsibility, ensuring they are compliant and effective. 
• Executes their QMS area(s) in accordance with governing internal policies / procedures and external standards and regulations.  This likely includes generation and approval of annual schedules, execution to schedule, approval of plans or reports, follow up on action items, facilitation of discussion s with participants and stakeholders to ensure success and compliance.
• Monitors the health of the QMS 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 QMS area(s) of responsibility during audits and inspections.
• Influences the organization in quality objectives, prioritization, and resourcing decisions as necessary.
• Manages team of direct reports in support of the above (as applicable).
• Manages and provides operational leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
• Acts as an internal champion for quality initiatives aimed at improving business systems and compliance; may be the primary representative of Quality group on projects.
• During audits and inspections, interfaces with global regulatory authority, notified body auditors and provides general support for the Quality group.
• Interfaces with QMS area owners and project teams from other Terumo BCT locations, regions, and corporate.

Education:

• Bachelor’s degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

Licenses or certifications:

• N/A.

Experience:

• Minimum 5 years’ experience.
• Preferred minimum 7 years’ experience in Quality Assurance and or Regulatory Affairs, involving US FDA Class II or Class III medical devices including knowledge & experience of applying global device laws & regulations for adverse event reporting and product recalls. 
• Minimum 2 years supervisory experience.
• Preferred training in FDA Quality System Regulation and ISO 13485.