Quality Engineering Specialist (Quality Systems)
Company: B. Braun Medical
Posted on: January 24, 2023
B. Braun Medical, Inc.
Quality Engineering Specialist (Quality Systems)
Job ID: 2022-21532
Type: Regular Full-Time
# of Openings: 1
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 .
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
Establishes quality standards for products and processes and
suggest modifications meant to prevent defects in components or
Works closely with cross functional teams, including product
design, product management and production, to identify and mitigate
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
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
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
Contacts are primarily with department supervisors, leads,
subordinates, and peers. Frequent contact with external
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.
Expertise: Qualifications -Education/Experience/Training/Etc
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
Through its "Sharing Expertise -" initiative, B. Braun promotes
best practices for continuous improvement of healthcare products
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.
While performing the duties of this job, the employee is expected
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
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,
Occasionally:Proximity to moving parts
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
Occasionally:Warehouse environment, Lab environment
Frequently:Office environment, Production/manufacturing
What We Offer
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.
Keywords: B. Braun Medical, Irvine , Quality Engineering Specialist (Quality Systems), Other , Irvine, California
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