Quality Engineering Specialist

B. Braun US Pharmaceutical Manufacturing LLC


Job Posting Location: Irvine, California, United States


Functional Area: Quality


Working Model: Onsite


Days of Work: Wednesday, Tuesday, Thursday, Friday, Monday


Shift: 5X8


Relocation Available: No


Requisition ID: 6048


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

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 process 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 of this position 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

• 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.

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 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.

Expertise: Qualifications -Education/Experience/Training/Etc

Required:

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

Schedule: M-F 8am-5pm
Salary range is $101,167 - $126,459

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.

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