Quality Engineering Specialist (Quality Systems)

Company: B. Braun Medical
Location: Irvine
Posted on: January 24, 2023

Job Description:

B. Braun Medical, Inc.

Quality Engineering Specialist (Quality Systems)

US-CA-Irvine

Job ID: 2022-21532
Type: Regular Full-Time
# of Openings: 1
Category: Quality
Irvine Facility

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 www.BBraunUSA.com .

Responsibilities

Position Summary:

This position will report directly to the QE manager of Investigations and will primarily be supporting the Excel manufacturing unit, with part-time support for QC support groups when a SME is needed. Roles and responsibilities will primarily be dictated by the QE Investigations manager, with support from the Product Line Leader for this area.

Responsibilities: Essential Duties
Supporting the investigation and closure of open line discrepancies in SAP. Other primary responsibilities will include helping QC support groups with complex investigations from an SME standpoint, as well as some other line support functions on an as needed basis.
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
This position requires someone with an in depth-knowledge of Quality Systems and Investigations management. Additional expertise that are crucial to the success of this position are a background in manufacturing process and/or Quality Control - Microbiology/Environmental monitoring areas.
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.
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.

Qualifications

Expertise: Qualifications -Education/Experience/Training/Etc

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 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 www.bbraunusa.com.

Through its "Sharing Expertise -" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

Additional Information

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

What We Offer

..

Notices

Equal Opportunity Employer Veterans/Disabled

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

PI201516658

Keywords: B. Braun Medical, Irvine , Quality Engineering Specialist (Quality Systems), Other , Irvine, California