Quality Engineering Team Lead, Blood Products

Position Summary

Provide entry-level leadership for quality engineering and design assurance activities related to the support of new product development and sustaining engineering up to and including technology transfer and commercialization. Supervise the activities and manage the performance of quality engineering staff. Strong understanding of GMP regulations and be able to identify and resolve quality issues with minimal consultation with Quality management.

Principal Responsibilities

•    Supervise quality engineering personnel. Provide feedback on employee job performance. Conduct performance reviews and recommend personal and professional growth opportunities.

•    Recruit, hire, onboard, and ensure the training of department additions to address resource needs.
•    Monitor production and laboratory operations to ensure compliance with cGMPs and Blood Product procedures.
•    Maintain and support required quality activities and programs for Blood Products
•    Independently performs quality review and approval of Blood Product documents, such as policies, standard operating procedures, work instructions, procedures, plans, study protocols/reports, specifications, and forms.
•    Identifies and resolves quality issues using problem-solving skills in consultation with management and other cross-functional departments, as needed.
•    Oversee activities involved with new product development and improvement, including product and process design, classification of quality characteristics, design inputs and review, technical drawings and specifications, and design verification and validation.
•    Participate in strategic planning and in the formation of department policies, procedures, organizational structure, and direction.
•    Identify, track and respond to metrics relevant to the department's performance.
•    Interact with management and engineering personnel to help establish priorities, allocate personnel, define project objectives and determine target completion dates.
•    Provide subject matter expertise and technical leadership in best-practice quality, reliability, design control, statistics, and risk management tools and techniques throughout all stages of our products' life cycle.
•    Support the development of risk management documentation such as risk analyses, FMEAs, and post-market surveillance documents. 
•    Support aspects of the company's improvement, remediation, and compliance projects including external quality system implementation and maintenance.
•    Contribute, as necessary, to R&D projects as the lead Quality Engineer. Participate in design and technical reviews as required.
•    Determine and review product and process testing methodologies and results to ensure reliability. 
•    Work with counterparts in other business units to implement technical and managerial best practices.
•    Own, support, and/or approve CAPAs or CAPA phases, NCs, and other corrective action and improvement efforts as required.
•    Apply project management skills in cost/schedule/resource planning as appropriate and assist others in doing the same.

•    Ensure compliance to the quality management system as well as national and international standards and regulations.
•    Review and, as appropriate, modify quality system records and documents to ensure compliance and effectiveness.
•    Defend the compliance of the department's processes and records during internal and external audits.
 

Education / Experience Requirements

•    B.A. or B.S. degree in a technical discipline, such as engineering or science (equivalent experience may be considered). 
•    Recommended 3-5 years of quality engineering or design assurance experience (preferably in the medical device industry).  
 

Specialized Skills / Other Requirements

•    Ability to train, mentor, and coach others.
•    Thorough understanding of industry regulations such as ISO 13485, ISO 14971 and FDA 21 CFR 210 - 211 and 600 - 640.
•    Proficient in MS Office, and Minitab or other statistical softwares.
•    Strong organizational and time management skills to meet deadlines while managing multiple projects.
•    Strong analytical and critical thinking skills.
•    Proficient in technical report writing and review.
•    Strong verbal and written communication skills. 
•    Foster a positive culture of growth, collaboration, adaptability to change, and achievement.
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