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Quality Manager - Doral, United States - Longwood University
Description
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UFP MedTech , a UFP Technologies, Inc (Nasdaq:UFPT) business, offers a full suite of design, development, process, and manufacturing services for single-use and single patient medical devices.
We create OEM devices, subassemblies, components and packaging, from Innovation to Manufacturing, using a differentiated flexible materials portfolio with best-in-class operational excellence systems to improve patient outcomes for our clients.
Our culture is centered around innovation, collaboration, creativity, and service. This is the connective tissue that drives our pursuit of industry leadership and customer partnerships throughout our organization.UFP Technologies, Inc.
offers a competitive benefits package, including but not limited to:
Medical, Dental, Vision, Life, Disability Insurance
401K with a matching contribution
Paid time off, Paid holidays, Employee discounts and much more
Location:
This position is based on-site in Newburyport, MA. The position holder will need to be within commuting distance (within 45 min). The position will be on-site full time.
Qualified applicants must be eligible to work in the United States to be considered for this opportunity. Employment based visa sponsorship (including H01B sponsorship) is not available for this position.
Quality Manager Summary:
The Quality Manager leads the continuous development, deployment, and improvement of the site Quality Management System (QMS) in Newburyport, MA which ensures a high state of cGMP compliance and supports the effective execution of UFPT objectives.
Activities will include developing, documenting, and maintaining technical business solutions or audits of data, policies, procedures, and systems to ensure compliance with Medical Device (21CFR 820s) and ISO 13485, ISO 14971, ISO 11607, ISO 9001, AS9100 and other worldwide regulations.
Reporting to the Director, Quality and Regulatory Compliance, the Quality Manager will partner with the site leadership to achieve strategic quality objectives.
The Quality Manager will watch key performance metrics defined both by the site and corporate, and partner to drive improvement.
The position will work closely with UFP across the organization to ensure alignment and execution of the Quality Management System.
Quality Manger Essential Duties and Responsibilities:
Develops, establishes, improves, and maintains the QMS elements, including policies, processes, procedures, and controls, which enable successful and efficient development and manufacturing of medical devices meeting customer and regulatory requirements.
Establishes QMS team goals and objectives for the group; cascades these objectives to team members.Collaborates with the site and corporate leadership team to establish Key Performance Indicators (KPIs) and develop Business Information Systems for the reporting of said indicators on a periodic basis.
Prioritizes quality engineering projects and assignments for completion by the appropriate quality personnel.Directs and manages the activities of Quality staff.
Interacts with site and corporate leadership on the performance of Quality systems.
Leads in the management review process.
Develops a robust system to assure corrective and preventive measures are systematically implemented and controlled.
Improves the efficiency of QMS leading simplification initiatives throughout the organization.
Develops relationships with professional organizations to stay abreast with current Best Practices relevant to QMS.
Partners with other function leaders for the successful development and introduction of new products in the organization following appropriate Good Manufacturing Practices and exceeding applicable regulations.
Maintains current knowledge and full compliance of national and international regulations regarding QSR, ISO, MDR, and quality assurance issues as they impact UFP QMS.
Manages the registration and device listings in the FDA registration system.Assists customers in the regulatory registration activities for MDR and other international regulatory bodies.
Leads the site team during external audits and inspections by customers and regulatory organizations.
Quality Manager
Education / Experience:
Bachelor's Degree in business or a scientific/technical field required. Advanced degree such as MBA or master's desired.
Minimum of 5 years' experience in multinational medical device, pharma/biopharma organizations, covering quality systems, and quality operations.
Demonstrated experience with Class II or Class III medical devices.
Broad knowledge and experience with quality systems, quality operations, regulatory compliance and understanding of current international regulatory requirements and trends for the manufacturing of medical devices.
Expert knowledge of ISO 13485, ISO 11607, ISO 14971 and 21 CFR Parts 11 and 820.Knowledge of ISO 9001, AS9100 and MDR preferred.
Knowledge of Project Management preferred.
Excellent analytical and statistical skills.
Ability to solve organizational problems.
Demonstrated experience in the development of Business Reports and Information Systems for the monitoring and reporting of site KPIs.
Experience in strategy development and deployment, organizational change, and business improvement.
Experience in the implementation of electronic Quality Management System platforms.
Demonstrate the ability to incorporate sound risk management fundamentals in the establishment of QMS following corporate guidance.
Demonstrates strong communication skills both verbally and written with excellent interpersonal, leadership, and motivational skills.
Ability to travel frequently, including internationally (5-15%) dependent on business needs.
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