The Quality Engineer will provide and analyze statistical information for quality improvement by identifying testing methods and samples. Plans and directs activities concerned with development, application, and maintenance of quality standards for industrial processes, material, and products:
In this role, you will be serving as a valuable resource on assurance standards, regulatory requirements and industry best practices; assisting in further developing the quality assurance and improvement program to align with industry best practices.
In this role, you will be developing professional expertise, applies company policies and procedures to represent the Quality Systems Department on software development teams as a software validation partner.
In this role, the selected candidate must be an individual with extensive knowledge of medical device quality system regulations (i.e. FDAs Quality System Regulation and ISO 13485) and the ability to develop, implement and maintain a quality system compliant with these requirements.
In this role, the selected candidate will provide assistance in performing disciplined problem solving for supplier, customer, and internal quality defect; maintains knowledge of all products, processes, and basic quality principles required to assist with daily operations and continual improvement activities.
The role is responsible for non-laboratory activities that ensure overall effective QC operations: specification document management, CoA generation, non-routine protocol review and coordination, LIMS builds, inspection preparation and support activities, and critical sample management.
In this role the CQE will provide detailed product inspection as mandated by corporate procedures and checklists to validate/verify product authenticity, condition and offer documented, factual information for Sales and/or Commodity Management to determine disposition when applicable.
In this role, you will manage individual customer self-release programs including procedure preparation and maintenance, purchase order/control review, inspection of parts (audit/sampling) for conformance to requirements, direct contact with customer representatives and handling any customer returns/complaints.
In this role, you will support Biosurgery Business by performing in-process, stability and release testing for Biosurgery Product lines. Serve as lead SME for assays associated with the product lines including technical proficiency in analytical chemistry (Spectroscopy, Chromatography, etc.)upport Biosurgery Business by performing in-process, stability and release testing for Biosurgery Product lines. Serve as lead SME for assays associated with the product lines including technical proficiency in analytical chemistry (Spectroscopy, Chromatography, etc.)
In this role, the selected candidate will conduct planning and research using a variety of database, internet, and industry tools, demonstrating clear understanding of client stakeholders and requirements and matching to the proposed solution.