Quality Engineer
6 days ago
As a Quality Engineer at Bio-Techne, you will play a critical role in ensuring the quality of our products and processes. Your responsibilities will include establishing statistical information for quality improvement, identifying quality systems process improvements, collecting feedback from clients to evaluate quality satisfaction, and analyzing information to apply technical understanding.
You will work closely with the Sales, Marketing, Supply Chain, Manufacturing, Manufacturing Engineering, Formulation & Filling, and Q.C. departments to support new products being transferred into manufacturing. You must understand and apply CFR 820 guidance, cGMP and ISO standards during product and process transfers into Manufacturing.
Your goal will be to aid manufacturing in achieving their goal of producing quality products efficiently and repeatedly with robust and streamlined processes and procedures. You will participate in new product introduction meetings for design review to ensure quality requirements are identified and captured in appropriate documentation.
You will lead FMEA teams and produce risk assessment reports for processes (pFMEA) and new products. You will review and approve validations (installation qualification IQ/operational qualification, OQ/performance qualification PQ protocols, Standard Operating Procedures (SOP), technical reports, and final reports) for new products, processes, and equipment; ensure systems, utilities, and processes comply with the Food and Drug Administration (FDA) and industry standards.
You will respond to and resolve customer complaints about products. You will be responsible for initial assessment and generation of Complaint Acknowledgement. You will coordinate complaint investigation with assistance of members of the CAPA/Complaint team. You will generate and share Complaint Response. You will develop procedures to aid in streamlining and improving product quality or reducing production waste. You will perform statistical analysis to assess products.
You will identify specific problems with a product's design or engineering. You will brainstorm new and innovative ways to increase production efficiency. You will exhibit ability to think creatively. You will actively participate in internal, customer and third-party audits. You will support QA team during third-party or customer audits as scribe and runner. You will participate in internal audits as part of QA team. You will complete ISO 13485 internal auditor training. You will assist with annual schedule of internal audits. You will perform verification to ensure cGMP training requirements is met.
You will provide initial training for QMS/GDP for new hires or schedules alternate. You will develop and lead training initiatives of team members as directed. You will lead Material Review Board meetings (MRB), assists with Non-Conforming Material Review (NCMR) reports. You will assist with generating change requests, corrective and preventive actions (CAPA) as needed. You will identify process improvement opportunities. You will devise ways to troubleshoot problems to ensure products are constructed appropriately. You will collaborate with other quality engineers and design staff to determine best production practices. You will identify and address documentation deficiencies. You will ensure process/product engineering and manufacturing activities are conducted in accordance with documented procedures, cGMP's and applicable regulatory requirements.
You will demonstrate ability to multitask. You will must have the ability to manage multiple projects with minimal supervision. You will work well with a team. You will communicate clearly and effectively with others. You will demonstrate respect and collaborative spirit with both internal and external customers. You will readily able to offer opinions and take action when the position may be unpopular. You will skilled at handling situations diplomatically. You will participate in Daily Management Meetings as tier 3 representation for QA. You will can translate technical engineering language to layman's terms for the purposes of presentations. You will follow company policies and practices as outlined in the Handbook, SOPs and SWIs and as well as follows guidelines regarding safety as outlined in the safety program and in accordance to the job function. You will manage time well and will put in extended time as needed. You will willingness to accept changes in work from day-to-day within reasonable and expected boundaries. You will perform other duties as assigned.
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