Quality Engineer II - Manufacturing

B. Braun Medical, Inc. Company: B. Braun US Device Manufacturing LLC Job Posting Location: Allentown, Pennsylvania, United States Functional Area: Quality Working Model: Onsite Days of Work: Wednesday, Tuesday, Thursday, Friday, Monday Shift: 5X8 Relocation Available: No Requisition ID: 4818 B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®. Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.bbraunusa.com (http://www.bbraunusa.com) Position Summary: Provide full quality support and expertise to others to achieve a high level of quality material, product, process, and test methods. Managing and performing root cause analysis and investigation studies for nonconformances, CAPAs and complaint trends. Serve as QA representative for material review board (MRB) meetings. Owner and execute quality improvement change controls. Provide risk assessment and an accurate action plan/solution that immediately mitigates impact on Quality and Production KPIs. Lead and execute equipment installation, qualification, and test method validation activities. Responsibilities: Essential Duties 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. 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 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. 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 kno