Sr. Quality Auditor
Company: B. Braun Medical
Posted on: May 15, 2022
B. Braun Medical, Inc.Sr. Quality AuditorUS-CA-IrvineJob ID:
2021-19351Type: Regular Full-Time# of Openings: 1Category:
QualityIrvine FacilityOverviewAbout 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 . ResponsibilitiesPosition Summary: 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:
- 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 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
- 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
- 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
- May periodically assist in orienting, training, and/or
reviewing the work of other peers.
- Judgement is required in resolving all day-to-day
- 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
- 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 and procedures.
- Must be reliable and capable of working with minimal
supervision to manage audit planning and execution, and follow-up
- 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 work location.
- 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 strongly preferred. QualificationsExpertise:
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. 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,
- 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 - ordinary, loud/quick
- Constantly:N/AEnvironmental Conditions:
- Occasionally: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:Production/manufacturing environment, Warehouse
environment, Lab environment
- Frequently:Office environment
- Constantly:N/A What We OfferB. 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
services.NoticesEqual Opportunity Employer Veterans/DisabledAll
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.PI177357113
Keywords: B. Braun Medical, Irvine , Sr. Quality Auditor, Accounting, Auditing , Irvine, California
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