Quality Systems Manager

B.

Braun Medical Inc.

Quality Systems Manager US-PA-Allentown Job ID: 2021-19674 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: This position is responsible for implementing, maintaining, improving and aligning the Quality Management System (QMS) for the Purchased Finished Goods and associated business units within the North America.

Specifically; reviewing, revising and maintaining the QMS procedures to ensure that the work conducted conforms to established corporate standards and industry regulations/standards.

The position also ensures the local execution of the change control, document control, learning management, CAPA, NCR and other Quality Management Systems.

Responsibilities: Essential Duties Establishes and maintains comprehensive site quality management systems that are efficient, effective and compliant to applicable cGMP, regulatory requirements and expectations, and the Company’s Quality System policies and procedures.

Manages the operation of the organization’s Quality System Group.

Oversees site supplier audit program activities to ensure compliance to applicable regulations.

Collaborates with Corporate Quality and additional company stakeholders to assure supplier management activities are in compliance to applicable regulations.

Maintains and continuously improves B.

Braun’s Quality Management System.

Ensures the internal / external audit programs are running effectively throughout the organization.

Plans and executes Customer and/or Third party Audit Partners with Corporate Quality to deploy consistent and compliant processes and procedures across the organization.

Lead Quality professionals in the monitoring, management and execution of Change Control (including labeling changes and control of IFUs on the IFU website).

Engages in root cause analysis and issue resolution when inefficiencies or discrepancies occur within the Change Control, Document Control and Training processes and systems.

Provides the business unit with consulting support for accurately processing procedures through the eDMS and development/maintenance of training assignments in accordance with corporate procedures.

Responsible for ensuring the entry of Site Level training records in the Learning Management System (LMS).

Responsible for the local process for issuing controlled documents, reconciliation and record retention in accordance with internal policies and regulatory requirements.

Maintains Quality Dashboard metrics for input into Management Reviews.

Tracks KPIs and the monitors the performance of the quality staff, ensuring that the department meets organizational objectives.

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 advanced knowledge of professional field and industry.

Influences the development of and drives the application of principles, theories, concepts.

Determines best course of action.

Provides direct or supervision to a group of employees, assigning tasks and checking work at frequent intervals.

Accountabilities include work and people scheduling, performance management and recommendations for hiring decisions.

Judgement is required in resolving complex problems based on experience.

Contacts are primarily with department supervisors, leads, subordinates, and peers.

Frequent contact with external contractors/vendors.

Qualifications Expertise: Qualifications -Education/Experience/Training/Etc Required: Bachelor’s degree required, Master’s degree preferred.

06-08 years related experience required.

Applicable industry/professional certification required.

Regular and predictable attendance Occasional business travel required, 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.

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, Stand, Visual Acuity with or without corrective lenses Frequently:Sit Constantly:N/A Activities: Occasionally:Seeing
– depth perception, color vision, field of vision/peripheral, Standing, Walking Frequently:Hearing
– ordinary, fine distinction, loud (hearing protection required), Sitting , Talking
– ordinary, loud/quick Constantly:N/A 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:Office environment, Production/manufacturing environment Constantly:N/A 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.