Quality Engineer
Job Summary The Quality Engineer reports to the Operations Engineering Manager and is responsible for continuous improvement of product quality through the entire manufacturing process from raw materials to customer receipt of finished products. Also, for creation and implementation of long-range strategic plans to increase production, for lean solutions to resolve individual process and equipment limitations, and for researching and writing associated procedures, standards, testing plans, and other supporting documentation. The Quality Engineer requires thorough understanding of electro-mechanical applications, strong verbal and written communication skills and robust professional workplace social skills, able to create and sustain successful partnerships within a wide range of research and manufacturing labs, Quality Assurance, Facilities, Supply Chain, and others. Essential Functions Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Identify, trend, analyze, and report quality challenges to improve product and process. Execute innovative solutions and validate results demonstrating sustained improvement. Assure products (current and new), materials and process, including their applicable documentation, are compliant with applicable QMS requirements. Provide quality engineering support to ensure adequacy of complaint, non-conformances, CAPA records, investigations, and corrective actions. Provide support both in analysis and the implementation of solutions for production failures Review process verification and validation reports to identify and correct compliance gaps. Write clear, concise, auditable, professional-quality procedures, standards, testing plans, and other supporting documentation. Partner with labs, engineering team members, and other stakeholders to deliver beneficial, flexible, permanent, cost-effective results quickly. Reduce cost and waste through improved processes and efficient deployment of financial, equipment, and human resources. Maximize efficient utilization of equipment, production processes, and environmental variables to improve safety, yield, capacity, and product quality. Support the QMS training program, including ISO13485, and regulatory requirements, and act as a resource to ensure quality compliance. Support customer, supplier, and regulatory audits, including timely document search and delivery during audits, as necessary. Provide quality guidance and leadership to new product development teams for design control, design verification, design transfer, process validation, risk management, new process training, and specification development. Support Management Review with metrics data on Quality processes. Perform other work, projects, or responsibilities as assigned. iACT Competencies innovate - Be better, keep improving, be more efficient, creative, and be in the forefront of development Aspire - Have desire, purpose, and ambition challenging ourselves to push the limits and reach new heights Collaborate - Foster teamwork, common goals, selflessness, communication and mutual support Transform - Adapt, learn, re-invent and change for future development and growth Minimum Qualifications - Education and Experience Engineering Bachelor of Science degree Five or more years manufacturing experience, preferably within biotechnology. Two years or more in a role directly supporting product quality. Experience managing improvement projectsin a regulated manufacturing environment. Excellent analytical and problem-solving skills. Demonstrated proficiency and practical application of Continuous Improvement tools (Lean Manufacturing, Lean Six Sigma DMAIC, Kaizen, 6S, Value Stream Mapping, A3, Root Cause Analysis, SPC). Preferred Qualifications - Education and Experience Master's Degree in Engineering, Biotechnology, or related field. Project management experience. Working knowledge of cGMP and other standard practices within the life sciences industry. Experience in mono and polynomial antibody and recombinant protein processing and manufacturing techniques and technologies. Condition of Employment Concerns regarding COVID-19 continue as positive cases are experienced in the communities in which we operate. Please be aware that, as a condition of employment, BioLegend requires proof of COVID vaccination for all U.S.-based employees (subject to limited exceptions) beginning January 18, 2022.
Salary Range:
$80K -- $100K
Minimum Qualification
Industrial Engineering, Mechanical EngineeringEstimated Salary: $20 to $28 per hour based on qualifications.
Salary Range:
$80K -- $100K
Minimum Qualification
Industrial Engineering, Mechanical EngineeringEstimated Salary: $20 to $28 per hour based on qualifications.
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