B. Braun

QA Quality Specialist II - Systems

Job Locations US-PA-Allentown
Requisition ID
2024-23685
Company
B. Braun Medical Inc
# of Openings
1
Category
Quality
Position Type
Hybrid Full Time
Shift
M-F; 8 AM - 5 PM
Site
Allentown, PA

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 Quality support for fulfilling OEM customer requests for data and information pertaining to the quality management system, product(s) manufactured for OEM customers, and production/processing of such products at B. Braun Allentown Operations.  Analyze and evaluate requested data and information and collaborate with OEM customers to determine actions needed by either party to drive continuous improvement.  Operate in accordance with company policies and procedures, FDA Regulations, ISO Standards and Canadian Medical Device Regulations. 

 

 

Responsibilities: Essential Duties

  • Conduct periodic review of Quality Agreements and Supplier Agreements and revise as necessary to support quality system and business changes. Support in establishing new OEM Quality Agreements and Supply Agreements.
  • Support OEM Design Assurance Engineers in the manufacturing transfer activities for new products including, but not limited to, the creation of Specifications, Drawings, Bills of Materials and Device Master Records.
  • In accordance with Company policies and procedures, serve as point of contact for OEM Sales organization to prepare responses to OEM requests for data and information related to the B. Braun quality management system, product(s) manufactured for OEM customers, and production/processing of such products at B. Braun Allentown Operations.
  • Conduct assessments and execution of changes for OEM customer products to assure compliance to Quality Agreement requirements.
  • Critical review of Quality Agreements to represent the interest of B. Braun.
  • Serve as liaison for Allentown Operations Quality organization for communications to OEM customers for quality issues including but not limited to, investigations and CAPAs.
  • Administrates, facilitates and maintains site quality management systems to ensure they are efficient, effective and compliant to applicable cGMP, regulatory requirements and expectations, and the Company’s Quality System policies and procedures.
  • Supports regulatory inspections, customer and/or Third Party Audit. Serve as backroom support for OEM customer audits, including data summarization and analysis. As required, serve as OEM audit host.
  • Provide direction, training, and mentoring for company personnel on policies in compliance with current GMP’s and corporate policy.
  • Ensuring that the quality system standards imposed by customers are not overlooked, yet do not compromise or conflict with internal B. Braun Requirements.
  • Understands and ensures regulatory compliance.
 
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

  • Knowledge of quality policies, FDA Regulations and ISO Standards for medical device or pharmaceutical operations.
  • Knowledge of CAPA, risk management, root cause investigation.
  • Proficient in the use of computers including a wide variety of software programs: BDocs, SAP, ISOTrain, Word, Excel, Project, and TrackWise.
  • 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 complex problems based on experience.
  • Contacts are primarily with direct supervisor, peers and subordinates.

 

 

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.

 

#ID
#LI

#MSL

Target Based Range

$79,022 - $98,777

Qualifications

Expertise: Qualifications -Education/Experience/Training/Etc

 

Required:

  • Bachelor's degree required or equivalent combination of education and experience.
  • 06-08 years related experience required.
  • Applicable industry/professional certification preferred.
  • Regular and predictable 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 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
  • Frequently:Stand, Sit
  • Constantly:N/A

Activities:

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

Environmental Conditions:

  • Occasionally:N/A
  • 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:Lab environment
  • Frequently:N/A
  • Constantly:Office 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

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