B. Braun

Sr. Quality Supervisor - Operations

Job Locations US-PA-Allentown
Requisition ID
2020-16873
Company
B. Braun Medical Inc
# of Openings
1
Category
Quality
Position Type
Regular Full-Time
Shift
8:00 am to 5:00 pm - hours may vary
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 61,000 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:

 

Supervises the activities for Quality Control Inspectors. Ensures continuous production of product in accordance with product specific quality control procedures and company policies and procedures. Assists in the maintenance of company policies and procedures to ensure compliance with regulatory compliance. Operate in accordance with company goals while complying with regulatory requirements.

 

Responsibilities: Essential Duties

  • Supervises employees, tasks and duties related to quality control within organization.
  • Develops, implements and assesses processes and policies designed to test products and services.
  • Monitors and evaluates current testing processes, making recommendations for improvements when necessary.
  • Understands and enforces quality, regulatory and safety compliance as related to the company procedures and law.
  • Conducts visual, dimensional and physical (functional) inspections of company products and materials.
  • Monitors the performance of the quality control staff, ensuring that the quality control department meets organizational objectives.
  • Responsible for personnel actions including (but not limited to) hiring, performance management and termination.
  • Directly supervise the work activities of employees engaged in quality inspections over multiple operating shifts to assure that products and processes meet company and regulatory requirements/standards.
  • Plan, recommend and coordinate testing of manufactured or purchased products.
  • Review, investigate, report and assist in the identification of product nonconformances. Assist with corrective actions to preclude the recurrence of similar issues.
  • Document discrepancy records, including containment, rework, root cause investigations, correction and corrective actions.
  • Track and monitor key process indicators related to quality control and implement programs designed to increase department and company employee awareness and knowledge of product nonconformities.  
  • Ensure non-conforming product is properly segregated and quarantined, products are properly identified with product status in accordance with company procedures and the results of all inspections are properly documented using good documentation practices in accordance with company policies and procedures.
  • Troubleshoot problems with QC testing equipment and assurance to calibration standards.
  • Provide support to the functional groups within the company on quality control inspection techniques.  
  • Assure efficient and economical utilization of materials and continuous improvement of methods to eliminate wasteful practices within the functional group.
  • Identify and implement quality system improvements when gaps are identified through audits and departmental reviews.
  • Responsible for training, development, motivating and counseling of subordinate staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies. Effectively communicate a variety of personnel actions; e.g., employment, termination, performance and salary reviews, disciplinary actions, scheduling and/or approving overtime.
  • Ensure personal training in accordance with department training matrix.
  • Provide input to budget development and ensure operations within approved department budget. Actively contribute to cost control methods.
  • Experience and/or understanding of injection molding processes producing componentry and final machine assembly. 
  • Experience reading product blueprints for dimensional inspection requirements for molded components.
  • Experience writing work instructions and procedures of quality control processes and review/approval of procedures.
  • Experience with change control system.
  • Experience with Maintenance records for preventative maintenance and unscheduled maintenance on machine equipment and test equipment.
  • Performs other related duties as required by management.
  •  

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

  • Operational experience and knowledge of quality policies, FDA Regulations and ISO Standards for medical device or pharmaceutical operations.  
  • Investigative, root cause analysis (RCA) and problem solving experience for nonconformances/deviations in paper based and/or electronic systems.
  • Experience and ability in leading a multifunctional material review board (MRB) team for product disposition.
  • Advanced knowledge of quality control inspection techniques. Ability to apply statistical techniques and quality tools.
  • Must be able to work with all functional groups.
  • Excellent verbal and written communication skills.
  • Strong attention to detail and accurate record keeping.
  • Strong organization abilities and problem-solving skills
  • Ability to work in a team environment.
  • Advanced computer skills including a word processing, and spreadsheet / data tracking analysis.
  • 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.
  • 04-06 years related experience required.
  • Applicable industry/professional certification preferred.
  • Regular and predictable 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.

 

 

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.

 

Other

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, Handling, Hearing - ordinary, fine distinction, loud (hearing protection required), Seeing - depth perception, color vision, field of vision/peripheral, Sitting , Standing, Talking - ordinary, loud/quick, Walking
  • 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:N/A
  • Constantly:Office environment

 

Notices

Equal Opportunity Employer Veterans/Disabled

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