Quality Project Manager

Position Purpose: The Quality Project Manager’s role is to assure high quality products and services that satisfy both internal and external requirements including meeting and exceeding customer expectations in compliance with regulatory requirements.

KEY RESPONSIBILITIES/ESSENTIAL FUNCTIONS:

• Assists Associate Director of Quality in coordinating and executing goals and objectivess throughout the company to improve product quality and operating system efficiency.

• Direct and coordinate the activities of Quality Department employees.

• Establish and maintain sound relationships with production, technology, supply chain, quality teams and cross functional personnel to identify system and compliance gaps with proposed resolutions.

• Act as liaison with metrology, QC and compliance team

• Ensure adherence to project and company standards, while maintaining quality systems that meet customer, internal, and regulatory requirements (ISO, cGMP, FDA, Health & Safety).

• Manage claims non-conformities, investigations, problem solving, root cause analysis, champion creation of effective and sustainable corrective actions.

• Manage process and equipment Validations for new product and existing business.

• Change control process owner

• Define and implement quality initiatives to meet KPI’s and objectives.

• Identify opportunities for improvement through data trending and analysis, as well as develop and implement quality and inspection processes. Engage in risk assessment process; data integrity, control and management utilizing risk assessment tools such as FMEA.

• Review and approve technical protocols, reports, and specifications, as appropriate.

• Participate and lead CAPA activities as required, utilizing problem solving techniques to reduce internal and external failures.

• Employ necessary tools/resources and perspectives, treating all co-workers with respect/dignity and valuing feedback.

• Responsible for the coordination and evaluation of the Quality department.

• Supervises staff in line with company policies and laws, including hiring, training, task management, performance evaluation, discipline, and conflict resolution.

• Make hiring decisions for their direct reports.

• Represent the Quality Department in support of customer, ISO and third-party audits.

• Other duties as assigned

• WORK ENVIRONMENT:

• Office and clean room environment that may include moderate noise levels and required appropriate PPE and cleanroom apparel

• Ability to travel between office and production departments as well as company buildings required