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Quality Engineer

  • LocationAllentown, PA 18109 - United States
  • Work TypeFull time
  • Positions1 Position
  • Published At:2 months ago
  • Job no: 42715
  • Category: Quality

Quality Engineer II US-PA-Allentown Requisition ID 2022-21651 Shift M-F 8:00 AM - 4:30 PM Responsibilities Position Summary: • Establishes quality standards for products and processes and suggest modifications meant to prevent defects in components or final products within the organization’s Distribution Centers. • Assists with execution of tasks associated with warehousing and distribution, including quarantine, storage under appropriate conditions, stock rotation, & inventory management. • Works closely with cross functional teams, including product design, product management and production, to identify and mitigate quality risks. • Audits logistics processes, including all aspects of holding and distribution, in accordance with applicable procedures and regulations, to ensure that established quality standards are met. • Conducts root cause analysis for defects, non-conformities or other quality failures. • May be responsible for ensuring compliance with formal external quality standards. Responsibilities: Essential Duties • Active member on Manufacturing Business Unit MRB team. Support containment, corrections and investigation for manufacturing nonconformances. Own and ensure appropriate material dispositions. • Lead Quality Continuous Improvement activities. Analyze manufacturing data, recommend and drive areas to reduce nonconformances and scrap. • Develop and improve test methods and inspection plans. • Work closely with Post-Market Surveillance team on complaints related to manufacturing quality. Drive root cause analysis, and implementation of corrective actions. • Responsible for Post-Market Surveillance trend investigations. Determine causal factors contributing to increased customer complaints. Perform risk assessment and recommend CAPA and HHA escalations. • Active member in CAPA investigations. Support root cause investigations and implementation of corrective actions. • Review Engineer Test Reports related to Process and Design Changes. Ensure appropriate data and testing is documenting to support changes. • Active member in site project teams. Collaborate with process engineering, product development and other cross functional teams and other cross functional groups in support of site improvement projects. The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time. General: It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons. Expertise: Knowledge & Skills • Requires full working knowledge of professional field and industry. • Influences the development of and drives the application of principles, theories, concepts. • Determines best course of action. • Work under general supervision. • Relies on experience and judgement to plan and accomplish assigned goals. • May periodically assist in orienting, training, assigning and checking the work of lower level employees. • Referring only complex problems and issues Specialized Knowledge & Skills o Minimum 4-year degree in an Engineering discipline – Mechanical, Biomedical, Industrial etc. o Working knowledge of ISO 13485 and 21 CFR 820 o 5-6 years in a GMP regulated environment. Preferably in a Quality Engineering role. o Problem-solving and knowledge of appropriate statical techniques. SPC, Linear Regression, DOE, Process Capability, Process Capability, Hypothesis Testing. o ASQ Certified Quality Engineer is a plus. o Six Sigma certification is a plus. o Self-starter with the ability to quickly learn about new processes, projects, and requirements o Ability to leverage influence and/or engage others to accomplish projects and deliverables. o Strong verbal and written communication skills, including the ability to write technical reports and communicate complex technical principles and concepts. Qualifications Expertise: Qualifications -Education/Experience/Training/Etc Required: • Bachelor's degree required. • 05-06 years related experience required. • Applicable industry/professional certification required. • Regular and predictable attendance • Occasional business travel required, Ability to work non-standard schedule as needed While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds. Additional Information Responsibilities: Other Duties: The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons. Physical Demands: While performing the duties of this job, the employee is expected to: • Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. Lifting, Carrying, Pushing, Pulling and Reaching: • Occasionally:Reaching upward and downward, Push/pull, Stand • Frequently:Sit • Constantly:N/A Activities: • Occasionally:Push/pull, Reaching upward and downward, Seeing - depth perception, color vision, field of vision/peripheral, Standing, Walking • Frequently:Finger feeling, Hearing - ordinary, fine distinction, loud (hearing protection required), Sitting , Talking - ordinary, loud/quick • Constantly:N/A Environmental Conditions: • Occasionally:Proximity to moving parts • Frequently:N/A • Constantly:N/A Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • Noise Intensity:Moderate • Occasionally:Warehouse environment • Frequently:Office environment, Production/manufacturing environment, Lab environment • Constantly:N/A What We Offer B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com. Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

  • Published on 29 Sep 2022, 2:00 PM