Job Description:

Title: Quality EngineerLocation: Hudson, WisconsinDuration: 10 Months with high possibility of extensionJob Description:Audit plant processes to ensure both internal and external regulations and standards are being adhered to.• Provide insight to improve processes and practices to ensure manufacturing quality is maintained while efficiency is optimized.• Assist management and training staff in communicating SOP and regulatory changes to involved staff and ensure documentation of training is complete.• Maintain Quality Assurance documentation.• Develop standard measurements for processes to be compared against.• Responsible for inspection and testing of processes and procedures - taking measurements and comparing to predefined standard.• Investigate when measurements are found that deviate from standards.• Ensure data integrity by auditing the manufacturing process to ensure the completeness, consistency, and accuracy of records and documents within the quality system.• Perform final quality assurance review and release for product shipments and associated documents to ensure shipments meet customer specifications.• Determine, negotiate, and agree on in-house quality procedures, standards and supporting documentation including interpretation and implementation of quality assurance standard.• Work with operations staff to establish adequate procedures, standards, and systems. Draft quality assurance policies and procedures and ensure review and approval in conjunction with other groups that impact the work conducted by the operations staff.• Driving the timely completion of SOP updates.• Identify training needs and organize training interventions to meet quality standards. Ensuring SOP curricula for roles within the group are current and accurate.• Develop, recommend, and monitor corrective and preventive actions to ensure that quality issues are resolved and prevented in future through proactive and coordinated employee training and process innovation.• Plan and conduct audits related to operations including, but not limited to, vendor audits, study site Quality Assurance audits, Trial Master File (TMF) audits, and site and sponsor pre-inspection preparation. Document internal audits and other quality assurance activities. Prepare reports to communicate outcomes of quality activities.• Acting as a catalyst for change and improvement in performance and quality across the group. Identify trends that could improve the quality of studies and data collection processesRequirement:Corrective actions, Microsoft Office, Scheduling, Investigating, Continuous Quality Improvement, Good Manufacturing Practices, Independent work, Supplier audits, Manufacturing processes• Previous relevant experience in quality assurance within a medical device, pharmaceutical, biotechnology, CRO, andor healthcare setting required.• Experience in design and development of quality plans and audit plans preferred.• Demonstrated analytical, negotiation, documentation, meeting management, and leadership skills are required.• Demonstrated knowledge of quality assurance processes including, but not limited to, planning and conduct of site and vendor audits, , Good Documentation Practices (GDP), and Quality Management Systems (QMS) is required.• Demonstrated ability to effectively interact with and collaborate at all levels in the organization and with external stakeholders, including effective interfaces at the senior management level.• Strong interpersonal, verbal and written communication skills.• Ability to form strong and constructive internal as well as external professional relationships.• Detail oriented, excellent organizational and management skills.• Must have the demonstrated core understanding of medical terminology and activities in relation to execution of a development plan.• Thorough knowledge of FDA guidelines and regulations.