Quality Engineer III

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Location :
Irvine, California

Expiry Date :
Sun, 06 Dec 2020 23:59:59 GMT

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Title: Quality Engineer III Location: Irvine, CA Job ID: 61291 col-wide Job Description: Overview 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 61,000 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 . Responsibilities Position Summary: This position will report directly to the QE manager of Line Support and will primarily be supporting manufacturing units, with part-time support for QC support groups when a SME is needed. Roles and responsibilities will primarily be dictated by the QE line support manager, with support from the Product Line Leader for this area. Responsibilities: Essential Duties – 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 9001. – Primary responsibilities will include supporting discrepancies on the manufacturing line, reviewing and approving controlled documentation, leading material review boards, and determining product disposition in a timely manner. – Other primary responsibilities will include helping QC support groups with complex investigations from an SME standpoint, as well as some other investigation functions on an as needed basis. 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 relevant business practices and procedures in professional field. Uses standard theories, principles and concepts and integrates them to propose a course of action. – Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, and/or reviewing the work of peers. – Judgement is required in resolving complex problems based on experience. – Contacts are primarily with department supervisors, leads, subordinates, and peers. Occasional contact with external contractors/vendors. – This position requires an in depth-knowledge of Quality Systems, Engineering Principles, and Quality Oversight management Preferred Requirements: – 2-3 years experience working for a QC support function including but not limited to Manufacturing, Chemistry, Microbiology, Sterilization, or Environmental Monitoring. Six-sigma experience. CQE. CQA. – Previous experience in a leadership role. Qualifications Expertise: Qualifications -Education/Experience/Training/Etc Required: – Bachelor’s degree required or equivalent combination of education and experience. – 06-08 years related experience required. – Applicable industry/professional certification preferred. – 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. 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 . Through its Sharing Expertise initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. Apply Here: PI