This position will be responsible for the creation, implementation and monitoring of all corporate & site Quality practices within their site of operation. Leading a team of quality professionals and driving a culture of continual improvement. Play a pivotal role and work collaboratively within the site management team, and drive quality engagement through all levels of the organization. Provide leadership and planning to develop, implement, and maintain quality systems to ensure compliance with regulatory, industry, and customer standards. Serves as the Management Representative for all site compliance and quality systems Supervises the activities of assigned staff and monitors the activities of QA/QC personnel within the QA Department. Assure that all resources utilized for the quality functions are procured, maintained, and perpetuated in a cost-effective and timely manner within the goals of the strategic business plan. Take the leadership role in maintaining/changing the quality culture of the company
- serve as the visible model of Quality.
Educate team members in the quality philosophy and practices, including improvement strategies. Represents the company to vendors, customers, and appropriate regulatory officials in matters related to quality. Administers the quality audit program. Provides training to team members, as required, for implementing quality initiatives. Work with cross-functional teams to prioritize key site projects and determine appropriate resources and timing; integrate lean six sigma activities with quality system activities such as Corrective and Preventive Action (CAPA) and Quality Improvements to assure effectiveness and compliance to customer and regulatory requirements. Develops annual quality plans and recommendations for continual improvement in conjunction with the Quality Leader and Operations Manager Determines methods and implements plans for professional development of personnel within the QA Department. Proposes budgets and monitors budget activity for the QA Department. Provides statistical analysis for evaluation of processes, and issue KPI reports to site leadership and divisional leaders at determined frequencies. Conducts lab tours and explains the quality system to visitors. Understands competitive product features in comparison to products. Completes required reports and summaries for regulatory & industry agencies. Assists and substitutes for the Divisional Quality Leader, as needed. Observes all safety rules and always uses the proper safety equipment. Performs other duties as necessary when directed to do so. Follows necessary GMP, FDA, and ISO regulations. Manage master validation plan. Implement, monitor and review online Quality systems, including vision QMS Software, and SPC systems. The ideal candidate should possess the following: Bachelor's degree in an Engineering, Technology, Mathematics, Business, or Science discipline. Three years minimum experience as a Quality Manager, Technical Manager, or QC Supervisor in a manufacturing environment (preferably FDA-regulated environment). Six sigma Green Belt certified, preferred. Supervisory experience. Auditing experience in GMP and/or ISO systems. ASQ Certification or equivalent training (CQE, CQA, CQT, or CQM). Advanced skills in oral and written communications. Standard skills in technical, business, and managerial fields. Standard skills in statistics, procedure implementation, and quality auditing. Competent in interactions with executive management, vendors, and customers.
Pay:
$100,000.00
00 per year
Benefits:
Relocation assistance
Work Location:
In person Quality Manager Mifflintown, PA 17059 $100,000
- $135,000 a year
- Full-time $100,000
- $135,000 a year
- Full-time This position will be responsible for the creation, implementation and monitoring of all corporate & site Quality practices within their site of operation.
Leading a team of quality professionals and driving a culture of continual improvement. Play a pivotal role and work collaboratively within the site management team, and drive quality engagement through all levels of the organization. Provide leadership and planning to develop, implement, and maintain quality systems to ensure compliance with regulatory, industry, and customer standards. Serves as the Management Representative for all site compliance and quality systems Supervises the activities of assigned staff and monitors the activities of QA/QC personnel within the QA Department. Assure that all resources utilized for the quality functions are procured, maintained, and perpetuated in a cost-effective and timely manner within the goals of the strategic business plan. Take the leadership role in maintaining/changing the quality culture of the company
- serve as the visible model of Quality.
Educate team members in the quality philosophy and practices, including improvement strategies. Represents the company to vendors, customers, and appropriate regulatory officials in matters related to quality. Administers the quality audit program. Provides training to team members, as required, for implementing quality initiatives. Work with cross-functional teams to prioritize key site projects and determine appropriate resources and timing; integrate lean six sigma activities with quality system activities such as Corrective and Preventive Action (CAPA) and Quality Improvements to assure effectiveness and compliance to customer and regulatory requirements. Develops annual quality plans and recommendations for continual improvement in conjunction with the Quality Leader and Operations Manager Determines methods and implements plans for professional development of personnel within the QA Department. Proposes budgets and monitors budget activity for the QA Department. Provides statistical analysis for evaluation of processes, and issue KPI reports to site leadership and divisional leaders at determined frequencies. Conducts lab tours and explains the quality system to visitors. Understands competitive product features in comparison to products. Completes required reports and summaries for regulatory & industry agencies. Assists and substitutes for the Divisional Quality Leader, as needed. Observes all safety rules and always uses the proper safety equipment. Performs other duties as necessary when directed to do so. Follows necessary GMP, FDA, and ISO regulations. Manage master validation plan. Implement, monitor and review online Quality systems, including vision QMS Software, and SPC systems. The ideal candidate should possess the following: Bachelor's degree in an Engineering, Technology, Mathematics, Business, or Science discipline. Three years minimum experience as a Quality Manager, Technical Manager, or QC Supervisor in a manufacturing environment (preferably FDA-regulated environment). Six sigma Green Belt certified, preferred. Supervisory experience. Auditing experience in GMP and/or ISO systems. ASQ Certification or equivalent training (CQE, CQA, CQT, or CQM). Advanced skills in oral and written communications. Standard skills in technical, business, and managerial fields. Standard skills in statistics, procedure implementation, and quality auditing. Competent in interactions with executive management, vendors, and customers.
Pay:
$100,000.00
00 per year
Benefits:
Relocation assistance
Work Location:
In person
