Senior Quality Engineer

About B. Braun 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 . Responsibilities Position Summary: • Establishes quality standards for products and processes and suggest modifications meant to prevent defects in components or final products. • Works closely with cross functional teams, including product design, product management and production, to identify and mitigate quality risks. • Audits production processes, raw materials or suppliers/vendors 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, such as ISO 13485. 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. Expertise: Knowledge & Skills • Requires advanced knowledge of professional field and industry. Influences the development of and drives the application of principles, theories, concepts. Determines best course of action. • Provides direct or supervision to a group of employees, assigning tasks and checking work at frequent intervals. Accountabilities include work and people scheduling, performance management and recommendations for hiring decisions. • Judgement is required in resolving complex problems based on experience. • Contacts are primarily with department supervisors, leads, subordinates, and peers. Frequent contact with external contractors/vendors. 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 8-10 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. o Strong decision-making capabilities including the ability to consider impact to customer, business and regulatory agencies. o Ability to work and determine priorities under limited supervision. Qualifications Expertise: Qualifications -Education/Experience/Training/Etc Required: • Bachelor's degree required, Master's degree preferred. • 08-10 years related experience required. • Applicable industry/professional certification required. • Regular and predictable attendance • Occasional business travel required, Secrecy and invention agreement and non-compete agreement, Ability to work non-standard schedule as needed