Operations Quality Lead

Job summary:

Work requires independent evaluation, in compliance with the guidelines given Drawing attention to the manager to any difficulties in understanding or following the guidelines, system efficiency, take responsibility for those safety aspects identified for the given position. Duties are assigned based on experience and familiarization with quality engineering methods, independent thinking, and medical industry practices and standards.

Essential duties:

• Establish robust quality operations plan to reduce defects and lead quality initiatives to improve and sustain product quality on a scale.
• Responsible for compliance in their corresponding areas with applicable Corporate and Divisional Policies and procedures.
• Review and make improvements on quality related processes and procedures where applicable.
• Recruits, coaches and develops organizational talent.
• Provides direction and guidance to exempt and/or supervisory staff. May Lead supervise quality supervisors and non-exempt employees.
• Keeps the organization's vision and values at the forefront of decision-making and action.
• Demonstrates effective change leadership.
• Builds strategic partnerships to further departmental and organizational objectives.
• Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).
• Makes decisions regarding work processes or operational plans and schedules to achieve department objectives.
• Incorporates business policies and procedures into task completion. Understands the business needs of the company and knows the customer needs of our business.
• Cultivates internal and external networks of resources to complete tasks. Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures. Interacts cross functionally and with internal and external customers. Serves as a consultant for supply chain, engineering or scientific interpretations and advice on significant matters.
• Mentors’ employees by sharing technical expertise and providing feedback and guidance.
• Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources.
• Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
• Monitors daily work operations and provides direction and guidance to lower-level supervisors, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals.
• Monitors internal and external indicators by reviewing reports and newsletters, reading organizational literature, meeting with peers and reading departmental reports.
• Contributes to the development and monitoring of area budget through regular analysis of cost and spending.
• Manage quality control requirements and risk analysis by enforcing and improving the workflow.

Education:

• Bachelor’s degree in engineering, Science, Management discipline or equivalent
• Fully Bilingual (English and Spanish) or advanced English / Required

Licenses or certifications:

• N/A.

Experience:

• 5 - 7 years in Quality with roles of increasing responsibility, impact, and scope within a manufacturing support environment.
• FDA Class II or Class III medical device experience.
• Solid knowledge of and experience working with international quality regulations, including US 21 CFR 820 (QSR) and ISO 13485.

Job summary:

Work requires independent evaluation, in compliance with the guidelines given Drawing attention to the manager to any difficulties in understanding or following the guidelines, system efficiency, take responsibility for those safety aspects identified for the given position. Duties are assigned based on experience and familiarization with quality engineering methods, independent thinking, and medical industry practices and standards.

Essential duties:

• Establish robust quality operations plan to reduce defects and lead quality initiatives to improve and sustain product quality on a scale.
• Responsible for compliance in their corresponding areas with applicable Corporate and Divisional Policies and procedures.
• Review and make improvements on quality related processes and procedures where applicable.
• Recruits, coaches and develops organizational talent.
• Provides direction and guidance to exempt and/or supervisory staff. May Lead supervise quality supervisors and non-exempt employees.
• Keeps the organization's vision and values at the forefront of decision-making and action.
• Demonstrates effective change leadership.
• Builds strategic partnerships to further departmental and organizational objectives.
• Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).
• Makes decisions regarding work processes or operational plans and schedules to achieve department objectives.
• Incorporates business policies and procedures into task completion. Understands the business needs of the company and knows the customer needs of our business.
• Cultivates internal and external networks of resources to complete tasks. Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures. Interacts cross functionally and with internal and external customers. Serves as a consultant for supply chain, engineering or scientific interpretations and advice on significant matters.
• Mentors’ employees by sharing technical expertise and providing feedback and guidance.
• Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources.
• Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
• Monitors daily work operations and provides direction and guidance to lower-level supervisors, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals.
• Monitors internal and external indicators by reviewing reports and newsletters, reading organizational literature, meeting with peers and reading departmental reports.
• Contributes to the development and monitoring of area budget through regular analysis of cost and spending.
• Manage quality control requirements and risk analysis by enforcing and improving the workflow.

Education:

• Bachelor’s degree in engineering, Science, Management discipline or equivalent
• Fully Bilingual (English and Spanish) or advanced English / Required

Licenses or certifications:

• N/A.

Experience:

• 5 - 7 years in Quality with roles of increasing responsibility, impact, and scope within a manufacturing support environment.
• FDA Class II or Class III medical device experience.
• Solid knowledge of and experience working with international quality regulations, including US 21 CFR 820 (QSR) and ISO 13485.

Job summary:

Work requires independent evaluation, in compliance with the guidelines given Drawing attention to the manager to any difficulties in understanding or following the guidelines, system efficiency, take responsibility for those safety aspects identified for the given position. Duties are assigned based on experience and familiarization with quality engineering methods, independent thinking, and medical industry practices and standards.

Essential duties:

• Establish robust quality operations plan to reduce defects and lead quality initiatives to improve and sustain product quality on a scale.
• Responsible for compliance in their corresponding areas with applicable Corporate and Divisional Policies and procedures.
• Review and make improvements on quality related processes and procedures where applicable.
• Recruits, coaches and develops organizational talent.
• Provides direction and guidance to exempt and/or supervisory staff. May Lead supervise quality supervisors and non-exempt employees.
• Keeps the organization's vision and values at the forefront of decision-making and action.
• Demonstrates effective change leadership.
• Builds strategic partnerships to further departmental and organizational objectives.
• Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).
• Makes decisions regarding work processes or operational plans and schedules to achieve department objectives.
• Incorporates business policies and procedures into task completion. Understands the business needs of the company and knows the customer needs of our business.
• Cultivates internal and external networks of resources to complete tasks. Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures. Interacts cross functionally and with internal and external customers. Serves as a consultant for supply chain, engineering or scientific interpretations and advice on significant matters.
• Mentors’ employees by sharing technical expertise and providing feedback and guidance.
• Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources.
• Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
• Monitors daily work operations and provides direction and guidance to lower-level supervisors, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals.
• Monitors internal and external indicators by reviewing reports and newsletters, reading organizational literature, meeting with peers and reading departmental reports.
• Contributes to the development and monitoring of area budget through regular analysis of cost and spending.
• Manage quality control requirements and risk analysis by enforcing and improving the workflow.

Education:

• Bachelor’s degree in engineering, Science, Management discipline or equivalent
• Fully Bilingual (English and Spanish) or advanced English / Required

Licenses or certifications:

• N/A.

Experience:

• 5 - 7 years in Quality with roles of increasing responsibility, impact, and scope within a manufacturing support environment.
• FDA Class II or Class III medical device experience.
• Solid knowledge of and experience working with international quality regulations, including US 21 CFR 820 (QSR) and ISO 13485.