Quality Operations Lead
Company: B. Braun Medical
Location: Irvine
Posted on: January 24, 2023
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Job Description:
B. Braun Medical, Inc.
Quality Operations Lead
US-CA-Irvine
Job ID: 2022-21899
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 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 www.BBraunUSA.com .
Responsibilities
Position Summary:
Under the direction of the Quality Operations Supervisor, oversees
the quality operations of production lines to ensure timely and
efficient quality testing of high quality health care products.
Main responsibilities include training, monitoring and coaching of
hourly employees for safe and compliant quality processes.
Responsible for performing process monitoring, quality support and
investigations/resolution.
Responsibilities: Essential Duties
Responsible for performing process monitoring, labeling control,
reinspection process monitoring and sampling process for Reserved
Samples.
Provides quality oversight on manufacturing processes to ensure
compliance including data integrity.
Provides routine work direction and training to other Quality
Operations Associates.
Escalates issues to Supervisor as required.
Provides support for quality investigations and resolution of
quality issues.
Use computerized systems needed for batch record documentation and
document control such as EBR (Electronic Batch Record) and SAP.
Provide sound quality decisions as need arises, i.e., product
segregations, line stops, and escalation to lead/supervisor as
necessary.
Perform all activities with a working knowledge of company
procedures and specifications.
Provide support to the manufacturing operation in all areas related
to quality.
Other duties as assigned by Quality Operations Supervisor.
Perform manufacturing process verifications to ensure compliance
with operating procedures and specifications.
Batch record review and review of quality documentation.
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
Please refer to the Corporate Guidelines or BBMUS Guidelines or job
specific authorities where applicable. This list is however not
exhaustive and may be amended by the Management from time to
time.
Requires working knowledge of technical field/area of
specialization. Exercises general application of principles,
theories and concepts. Follows established procedures and
guidelines.
Works under general supervision. May periodically assist in
orienting, training, assigning & checking the work of other
peers.
May require some limited judgement in resolving problems.
Contacts are primarily with department supervisors, leads,
subordinates, and peers. Occasional contact with external
contractors/vendors.
Qualifications
Expertise: Qualifications - Experience/Training/Education/Etc
Required:
High school diploma required, Bachelor's degree in a Science
related field preferred.
04 - 06 years related experience required.
Ability to work non-stand schedule as needed
Regular and predictable on-site attendance
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 40 pounds.
Additional Information
Responsibilities: Other Duties:
Physical Demands:
The physical demands described here are representative of those
that must be met by an employee to successfully perform the
essential functions of this job. Reasonable accommodations may be
made to enable individuals with disabilities to perform the
essential functions.
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: Sit
Frequently: Reaching upward and downward, Push/pull, Stand
Constantly: N/A
Activities:
Occasionally: Sitting
Frequently: Handling, Hearing - ordinary, fine distinction, loud
(hearing protection required), Push/pull, Reaching upward and
downward, Seeing - depth perception, color vision, field of
vision/peripheral, Standing, Talking - ordinary, loud/quick,
Walking
Constantly: N/A
Environmental Conditions:
Occasionally: N/A
Frequently: Proximity to moving parts
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, Lab environment
Frequently: N/A
Constantly: Production/manufacturing environment
What We Offer
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.
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.
PI201516691
Keywords: B. Braun Medical, Irvine , Quality Operations Lead, Other , Irvine, California
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