Senior Quality Assurance Specialist This position is responsible for investigating, planning and implementing improvements in quality system that ultimately result in a better quality product and improved manufacturing efficiency. The position is involved with leading projects of moderate scope and requires Quality Assurance (QA) team effort and/ or a multi-discipline team effort. The position assigns, delegates and assists in providing QA related duties or projects to lower level QA staff. The position includes ensuring compliance to quality policy, responding to customer complaints, scheduling and performing audits, and reviewing/ writing procedures as required. Maintain and follow proper compliance and quality systems requirements Oversee the site’s Complaint Handling Systems (Product Performance Reports (PPRs)) utilized by our client including review and approval of customer response letters. Generate medical Device Reports (MDRs) within Complaint Handling System Responsible for Internal Audit program (scheduling, training auditors, implementation of audit plan). Plan, implement and lead projects to be completed- includes organizing and coordinating resources (personnel, materials, time, money, etc.) Assist with Document Center activities- including Change Order processing through software platform Oversee assigned QA programs (such as Stability Testing, etc.) Assign, delegate and assist in providing QA related duties or projects to lower level QA staff. Attend meetings and prepare monthly reports as required Prepare monthly PPR reports for presentation to Senior Management Communicate effectively with customers- both orally and in writing Participate in external audits Performs other duties as assigned Requires a four-year degree with at least 6 years of quality assurance experience, CQE and/ or CQA certification strongly preferred. Understanding of basic engineering principles, intermediate level of computer software skills (i.e. Microsoft Office products). High level of communication skills both verbal and writing a must. Proven ability to lead project work. Knowledge of GMP/FDA/ISO/CMDR regulations Must have strong training skills. Various levels in sections within company for related projects or progress (i.e. daily interactions with various levels in the organization. Counterparts at other company facilities to promote the improvement of the quality system. Customers and Vendor contacts regarding audits, customer complaints and service. This position requires strong analytical and problem solving skills, the ability to solve complex problem, and implement solutions or processes for manufacturing. Must be very strong at making independent decisions bases upon incoming data. Requires strong knowledge of the entire product line, manufacturing processes and a thorough understanding of Quality Assurance principles and practices. This position has the responsibility for all aspects of the products manufactured/ equipment in terms of performance, safety, reliability, and quality. The work performed effects the work of other departments and quality assurance, the impression of our product on customers and the overall cost savings of the company. Location: Newark, DE Compensation: $60K - $65K/year Principals only. Recruiters, please don't contact this job poster. Phone calls about this job are ok. Please do not contact job poster about other services, products or commercial interests. delaware