Sr Quality Auditor
Company: B. Braun Medical
Posted on: January 24, 2023
B. Braun Medical, Inc.
Sr Quality Auditor
Job ID: 2023-22309
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 .
The Quality Auditor is responsible for all activities related to
the execution of internal audit, Supplier Audit, compliance
walkthrough, and for management of Regulatory Agency Inspections.
The auditor is responsible for the overall audit program management
at the site to ensure compliance with internal policies and
regulations and Inspection Agency expectations.
Responsibilities: Essential Duties
Develops annual supplier audit schedules in conjunction with site
leadership and procurement.
Monitors performance to schedule, report on schedule attainment and
work with site leadership to meet the audit schedule.
Ensures that the supplier audit program and associated procedures
and forms meet regulatory compliance requirements and are aligned
with industry best practices
Perform supplier and internal quality system audits including
execute and prepare audit report on a timely basis.
Maintains files generated from each audit.
Performs necessary Follow up which include communicating with
auditee(s) on status of action resolution.
Responsible for activities related to internal audit, Supplier
Audit, and Regulatory Agency Audit.
Responsible for tracking audit schedule, scheduling audit,
executing audit, reporting, and closing out audit.
Responsible for weekly, by weekly and monthly audit activity
Manages audit tasks to achieve department guidelines and within
established timetables with high quality results.
Identifies process risks and controls and performs an assessment to
determine audit scope.
Develops the audit program, manages the execution of the audit,
including reviewing and analyzing evidence and ensuring appropriate
conclusions are reached.
Drafts high quality reports and ensures findings and actions are
well documented in accordance with department standards.
Ensure that audit responses use appropriate root cause analysis.
Follow-up audit results by seeking appropriate corrective actions
if deficiencies are noted.
Consults through ad-hoc advisory engagements while working
hand-in-hand with business units as they are working on audit
Schedule meetings, take meeting note, follow up on action items
from meetings activities.
Track implementation of corrective actions and verify actions for
Support management on tracking audit activities and administration
of audit schedule.
Support external audits.
Take integral role in Regulatory Agency (i.e. FDA, Health Canada,
EU, etc.) which includes leading and directing the back room/war
Participate in inspection readiness activities by working in
collaboration with Corporate and local employees.
Lead and support projects and initiatives to achieve Quality
Compliance objectives and any other departmental objectives (e.g.,
Inspection Readiness activities, Supplier Quality activities,
training, Quality Systems initiatives, etc.).
Preparing Annual Periodic Review reporting as assigned.
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.
Works under general supervision.
Relies on experience and judgement to plan and accomplish assigned
May periodically assist in orienting, training, and/or reviewing
the work of other peers.
Judgement is required in resolving all day-to-day problems.
Contacts are primarily with department supervisors, leads,
subordinates, and peers.
Occasional contact with external contractors/vendors.
Must be familiar with all aspects and elements of internal and
Fast learner with can-do attitude, adaptable to change, flexible,
and able to work in a fast-paced environment that is evolving.
Must be familiar with aspects of quality system including but not
limited to corrective and preventive action (CAPA), management
responsibility, Non Conformance, Change Control, Supplier Quality,
Must have basic knowledge of manufacturing processes and the
ability to work towards in-depth understanding processes and
Demonstrated knowledge of Quality Systems Regulations and be able
to quickly develop a thorough understanding of internal policies
Must be reliable and capable of working with minimal supervision to
manage audit planning and execution, and follow-up activities.
Experience or knowledge on issue resolution disciplines (e.g.,
problem solving/decision making, root cause analysis, etc.).
Highly compliance oriented to adhere adhere to the principles of
the regulations and standards.
FDA , Health Canada or other regulatory body experience.
Strong both writing and oral communication skills.
Strong interpersonal skill, independent and self-starter, flexible,
and willing to take on supporting role.
Strong leadership, organizational, admirative albitites.
Self-motivated individuals could have periodic flexibility in their
Strong project management abilities preferred.
Basic data analysis, reporting, and power point presentation
abilities is strongly preferred.
Occasional travel that may be up to 10 %.
Quality auditng experience required.
Strong skills in MS Office applications or equivalent
Pharmaceutical regulations knowledge and experience is
Data Analysis, reporting, and power point presentation abilities
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.
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, Stand
Occasionally:Push/pull, Reaching upward and downward, Standing,
Frequently:Finger feeling, Hearing - ordinary, fine distinction,
loud (hearing protection required), Seeing - depth perception,
color vision, field of vision/peripheral, Sitting , Talking -
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:Production/manufacturing environment, Warehouse
environment, Lab 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
Through its Sharing Expertise - initiative, B. Braun promotes best
practices for continuous improvement of healthcare products and
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 , Sr Quality Auditor, Accounting, Auditing , Irvine, California
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