Quality Engineer III

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: 9526


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:

The Quality Engineer III will provide technical Line Support to ensure product quality is built into processes. Primary focus will be to maintain the Quality System and provide support for process improvements to prevent discrepancies from occurring. Other duties include reviews and approves documentation such as protocols, reports, specifications, maintenance work orders and other documentation.

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, technical services 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 using the DMAIC principles for defects, non-conformities or other quality failures.
• Able to complete and present technical analysis and assessments.
• Performs process impact assessments and product risk assessments as needed
• 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 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.

Expertise: Qualifications -Education/Experience/Training/Etc

Required:

• Bachelor's degree required.
• 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.

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. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

Physical Demands:

While performing the duties of this job, the employee is expected to:

• Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.

Lifting, Carrying, Pushing, Pulling and Reaching:

• Occasionally:Reaching upward and downward, Push/pull
• Frequently:Stand, Sit
• Constantly:N/A

Activities:

• Occasionally:Finger feeling, Handling, Hearing - ordinary, fine distinction, loud (hearing protection required), Push/pull, Reaching upward and downward
• Frequently:Sitting , Standing, Talking - ordinary, loud/quick, Walking
• Constantly:N/A

Environmental Conditions:

• Occasionally:Proximity to moving parts
• Frequently:N/A
• Constantly:N/A

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Noise Intensity:Moderate
• Occasionally:Office environment, Production/manufacturing environment, Warehouse environment, Lab environment
• Frequently:N/A
• Constantly:N/A

$108,400.00 - $118,400.00/Annually