Sr Quality Auditor

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

Job Description:

B. Braun Medical, Inc.

Sr Quality Auditor

US-CA-Irvine

Job ID: 2023-22309
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:

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 reporting.
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 responses.
Schedule meetings, take meeting note, follow up on action items from meetings activities.
Track implementation of corrective actions and verify actions for effectiveness.
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 room.
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 goals.
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 external audit.
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, etc.
Must have basic knowledge of manufacturing processes and the ability to work towards in-depth understanding processes and products.
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 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 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 preferred.
Pharmaceutical regulations knowledge and experience is required.
Data Analysis, reporting, and power point presentation abilities strongly preferred.

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.

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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, Stand
Frequently:Sit
Constantly:N/A
Activities:
Occasionally:Push/pull, Reaching upward and downward, Standing, Walking
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/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:Production/manufacturing environment, Warehouse environment, Lab environment
Frequently:Office environment
Constantly:N/A

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.

PI201801611

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