QA Quality Specialist II - Sys

B. Braun Medical, Inc.

Company : B. Braun US Device Manufacturing LLC

Job Posting Location : Allentown, Pennsylvania, United States

Functional Area : Quality

Working Model : Onsite

Days of Work : Friday, Thursday, Wednesday, Tuesday, Monday

Shift : 5X8

Relocation Available : No

Requisition ID : 7645

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

Position Summary :

• Administers, 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
• Supports internal audits (as CAPA SME)
• Understands and ensures regulatory compliance
• Responsible for review and approval of root cause investigations and corrective / preventive actions for CAPAs resulting from a variety of technical problems of moderate to complex scope
• Work closely with CAPA owners to ensure compliant and on time closure of CAPAs
• Support Operations and Quality through effective review and approval of CAPAs
• Drive continuous improvement efforts through facilitating, leading, and collaborating with cross functional teams

Responsibilities : Essential Duties

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

Expertise : Qualifications -Education / Experience / Training / Etc

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.

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 :

Lifting, Carrying, Pushing, Pulling and Reaching :

Activities :

Environmental Conditions :

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.

Salary Range : $81,392 - $101,740

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.

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.

We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights : Workplace Discrimination is Illegal, click here .

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.

Please see job description

PI278603618