QA Product Release Administrator at B. Braun Medical Inc. in Allentown, Pennsylvania

Job Description:

B. Braun Medical, Inc.


QA Product Release Administrator

US-PA-Allentown

Job ID: 2024-24988
Type: Regular Full-Time
# of Openings: 1
Category: Quality
Allentown Mfg 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:

Provide certificates of compliance and related documentation to meet customer requirements for finished goods released for distribution. Assist in review and evaluation of Device History Records (documentation related to finished product lots) to ensure that only products which meet design and Quality System requirements are released for distribution and sale. Compile and archive all Device History Records in accordance with FDA requirements and ISO standards.

Responsibilities: Essential Duties

• Provides certificates of compliance and related documentation to meet customer requirements for finished goods released for distribution.
• Assists in review and evaluation of Device History Records (documentation related to finished product lots) to ensure that only products which meet design and Quality System requirements are released for distribution and sale.
• Compiles and archives all Device History Records in accordance with FDA requirements and ISO standards.

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

Expertise: Knowledge & Skills

• 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.

The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.

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Target Based Range

$53,000 - $58,000

Qualifications

Expertise: Qualifications -Education/Experience/Training/Etc

Required:

• High school diploma/G.E.D or equivalent required, Associate's or technical degree preferred.
• 02-04 years related experience required.
• Applicable industry/professional certification preferred.
• Regular and predictable on-site attendance
• Secrecy and invention agreement and non-compete agreement, Ability to work non-standard schedule as needed

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:N/A
• Frequently:Reaching upward and downward, Push/pull, Stand, Sit, Visual Acuity with or without corrective lenses
• Constantly:N/A

Activities:

• Occasionally:Push/pull, Reaching upward and downward
• Frequently:Finger feeling, Hearing - ordinary, fine distinction, loud (hearing protection required), Seeing - depth perception, color vision, field of vision/peripheral, Talking - ordinary, loud/quick
• Constantly:Standing, Walking

Environmental Conditions:

• Occasionally:Proximity to moving parts, Exposure to toxic or caustic chemicals (in most areas)
• 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:N/A
• Frequently:N/A
• Constantly:Office environment, 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.

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Salary:

$58,000.00

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