ProAmpac Holdings, Inc. Sr Quality Manager in Rochester, New York
ProAmpac's Collaboration and Innovation Center (CIC) is located at the ProAmpac -- Rochester site. The CIC will play an important role in accelerating ProAmpac's product development, application testing and anticlerical capabilities. The Sr. Quality Manager will be the face of ProAmpac's Collaboration and Innovation Center (CIC) as it relates to quality and the Subject Matter Expert (SME) for all matters ISO 13485. The Sr. Quality Manager will be responsible to guide and support the quality staff as it relates to day to day activities and will have ultimate responsibility and accountability for the measured quality metrics. ProAmpac is building a medical device business within a successful existing operation to design, formulate and certify on the medical device side.
Responsible for ensuring that the Integrated Management System (ISO, GFSI, GMP) is being followed.
Work in conjunction with Manufacturing Management to ensure that all manufacturing and Quality Assurance procedures are being performed through documented process monitoring and process controls methods.
Responsible for ensuring that all quality personnel are trained to perform their respective job functions.
Responsible for the direct supervision of the QA supervisor(s).
Participate in the establishment of quality specifications.
Representing ProAmpac to new and existing customers.
Work in conjunction with Senior Sales Leaders to create product plans for new business opportunities (NBO).
Responsible for all activities associated with external audits.
Manage customer complaint and reject process to ensure accurate root cause analysis, timely response, and determination and implementation of corrective actions.
BS Degree in technical area plus 10 years' experience in Quality/Manufacturing/Management or 15 years' relevant experience.
Proven experience in product development or similar.
Prior audit experience and knowledge of ISO 9001, GMP, GFSI required.
Subject matter expert on ISO 13485 and previous knowledge of the medical device industry.
Fully integrated management system oversight which includes food safety, regulatory and quality management systems.
Black belt six sigma certification preferred.
Demonstrated understanding of fact-based decision-making and analytical processes related to quality management and process improvement.
Effective coaching, training and facilitating experience.
Area of Interest: Quality
ProAmpac is an Equal Opportunity Employer: Minorities/Women/Protected Veterans/Disabled.