QA Engineer II

Company: B. Braun US Pharmaceutical Manufacturing LLCJob Posting Location: Irvine, California, United StatesFunctional Area: QualityWorking Model: OnsiteDays of Work: Wednesday, Thursday, Tuesday, Friday, MondayShift: 5X8Relocation Available: NoRequisition ID: 3933

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 support 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 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. Using established policies and procedures, the incumbent will work 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.

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.
• Works under general supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, assigning & checking the work of other peers.
• Judgement is required in resolving all day-to-day problems
• Contacts/Cooperation:
• Contacts are primarily with department supervisors, leads, subordinates, and peers. Occasional contact with external contractors/vendors.

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$83,610 - $104,509

Expertise: Qualifications - Experience/Training/Education/Etc

Required:

• Bachelors degree required
• 4-6 years related experience required.
• Occasional business travel required

Desired:

• Applicable industry/professional certification preferred.

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: Warehouse environment, Lab environment
• Frequently: Office environment, Production/manufacturing environment
• Constantly: N/A

Equal Opportunity Employer Veterans/Disabled

The targeted range for this role takes into