Quality Operations Lead

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

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