Quality Engineering Specialist

Overview

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 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.

Location:

Irvine, California, United States.

Functional Area:

Quality. Working Model:
Onsite. Days of Work:
Tuesday, Wednesday, Thursday, Friday, Monday. Shift: 5X8. Relocation Available:
No.

Position Summary: Provide Quality Engineering leadership to production for quality activities and maintain oversight of manufacturing activities for quality compliance, while assuring that products and processes continue to operate in accordance with company policies and procedures. Together with the Manufacturing, Technical Services, Quality Operations and QC Process Control teams, the incumbent will be accountable for the performance of their assigned operational area against key business objectives such as safety, quality, compliance, and production costs/output.

The incumbent will drive peers to manage performance of equipment, systems, and processes; and will work to improve the output, efficiency or quality of the associated manufactured products.

Responsibilities:
Essential Duties

• Establish quality standards for products and processes and suggest modifications meant to prevent defects in components or final products.
• Work closely with cross functional teams, including product design, product management and production, to identify and mitigate quality risks.
• Audit production processes, raw materials or suppliers/vendors to ensure that established quality standards are met.
• Conduct 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.

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.
• 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. Frequent contact with external contractors/vendors.

Qualifications

Education/Experience/Training

Required:

• Bachelor's degree required.
• 08-10 years related experience required.
• Applicable industry/professional certification preferred.
• Regular and predictable attendance
• Occasional business travel required

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is frequently 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 knowledge, skill, and/or ability required.…