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Nemera is a leading global manufacturer of complex drug delivery systems for the pharmaceutical industry. The Quality Project Manager will assist in coordinating goals to improve product quality and system efficiency, direct Quality Department activities, and ensure compliance with regulatory standards.
Job Responsibility:
Assists Associate Director of Quality in coordinating and executing goals and objectives 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
Requirements:
Bachelor’s degree in Engineering or related field
4+ years of relevant working experience in Quality in a manufacturing environment
1+ year experience in a supervisory role
Excellent communication skill with the ability to understand, read, write, and speak English
Ability to apply advanced mathematical concepts and intermediate statistical (SPC) knowledge
Strong understanding of injection molding, Automation and FMEA
Knowledgeable to equipment/process/product validation practices and principles
Excellent interpersonal, organizational and communication skills
Demonstrated leadership and the ability to motivate and influence others
Able to lift up to 30 lbs
Ability to push and pull items
Ability to sit, stand, walk 80% of shift required
Nice to have:
Self-directed and possess knowledge of business and management principles involved in strategic planning, resource allocation and coordination of people and resources
Knowledge of inspection tools, including their design, use, repair and maintenance
Medical device and/or Pharmaceutical Industry experience preferred
Six sigma training and/or certifications preferred
Demonstrated organizational skills and general knowledge of PC applications such as Microsoft Word, Excel and Database software such as SAP
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