Quality Specialist II

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:

Provide Quality oversight over the Quality System, including but not limited to the review SOPs, protocols, reports, data (included meta data) and records generated to support the manufacturing and distribution of product.

Responsibilities: Essential Duties

• Conducts timely Quality review of associated data, including data utilized to support batch release, to meet business and operations requirements.
• Assists in complying with regulatory requirements related to product safety and quality.
• Ensures that procedures are being followed as outlined under FDA, ICH, Standard Methods and the Quality System requirements.
• Reviews records to ensure data meets the industry requirements for data integrity.
• Provides input and quality oversight over investigations, which includes review and approve the investigation reports.
• Provides Quality oversight over equipment/software qualification, calibration and validation.
• Partners with Corporate Quality to implement centralized processes and ensures compliance to industry standards and compendial requirements.
• May act as a "lead" or first-level supervisor and may provide leadership, coaching, and/or mentoring to a subordinate group.
• 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 person.

Expertise: Knowledge & Skills

• Requires advanced knowledge of professional field and industry. Influences the development of and drives the application of principles, theories, and concepts. Determines best course of action.
• Working knowledge of quality policies and thorough understanding of FDA Regulations and ISO Standards for pharmaceutical or medical device operations.
• Understanding of CAPA, document control, product release, management of external audits, internal audit systems, validation, data monitoring and statistical control
• Strong analytical, communication, critical thinking, and prioritization skills.
• Ability to work autonomously within established guidelines, procedures and practices.
• Advanced and specialized expertise typically developed through a combination of job-related training and considerable on-the-job experience as related to a regulated industry.
• Ability to analyze and propose process improvements.
• Must be able to effectively manage multiple priorities

Expertise: Qualifications - Experience/Training/Education/Etc

Required:

• 4-8 years of related experience (equivalent experience with Associate's degree 6-10 years)
• Bachelor's degree in related field required or Associate's Degree and equivalent experience.

Desired:

• 1 or more years supervisory experience preferred.
• Applicable industry certification preferred.

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:

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.

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. The noise level in the work environment is usually moderate.

Salary: $91,969 - $114,959/ Annually

#LI

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.