Nolato is a part of the Nolato group. Nolato is a Swedish publicly listed group with operations in Europe, Asia and North America. We develop and manufacture products in polymer materials such as plastic, silicone and TPE. Nolato GW Plastics is a global leader in precision injection molding and contract manufacturing to the world’s most successful companies. Join an organization that is respected throughout the industry for its advanced technology, quality, and innovation – all the while enjoying the benefits of stable ownership, a collaborative culture, professional development, continuing education, global opportunities, and an exceptional benefits package.

Specific Functions:

• Supervise and direct quality assurance technicians/auditors who are responsible for enforcing Good Manufacturing Practices and other quality related policies in order to meet product quality standards.
• Review Production Batch Records and other manufacturing related documents to verify compliance and record keeping for all mandated manufacturing processes, quality checks, testing, sampling and sanitation activities.
• Oversee the "On Hold" and "RMA" product program, including the status, release and destruction of "Rejected" products.
• Assist in investigating and correcting quality related issues (including customer complaints) through collaboration with other departments.
• Assist in the implementation of policies, operating procedures, quality systems and programs which ensure proper testing, evaluation, inspection, and technical support in order to meet product quality standards.
• Ensure good performance by quality assurance technicians/auditors by mentoring, training, setting expectations, providing accountability and performing evaluations.
• Investigate product, and process deviations, identify root cause, and develop corrective and preventative actions.
• Provide leadership and direction to QA Techs by managing the workload, training and employee relations issues.

Experience:

• Minimum of five years' quality experience in an ISO 13485 and FDA regulated production environment, including supervision.
• Be well versed in ISO 13485 and 21CFR 820 Quality Management Systems requirements. Experience with ISO 14001 Quality Management System requirements a plus.
• Demonstrated expertise in building Quality Plans including strategy and tactics that have successfully met Quality KPI's and Quality goals.
• Experience in Lean, FMEA, MRB, NCMR, CAPA, Root Cause Analysis, IQ/OQ/PQ Validations, Supplier Management, Internal Auditing, Key Characteristics and establishing Quality Metrics.
• Excellent written and verbal communications skills across a broad variety of departments.
• Ability to positively and comfortably handle and prioritize multiple tasks in a fast paced environment with self-motivation and focused attention to detail.
• Ability to develop protocols, training materials and reports with guidance of resources.
• Self starter; take charge, positive and proactive attitude.