3 days old

Supervisor II, Quality Control

Allentown Mfg Facility
Allentown, PA 18109
  • Job Code
    119340138

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 policies and procedures, FDA Regulations, ISO Standards and Canadian Medical Device Regulations, where applicable.

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 and physical 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.
  • 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.
  • 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.

Required:

  • Prior Quality experience or combination of Quality and Manufacturing.
<br /><b>Overview</b><br/><br /><p style="margin-bottom: .0001pt;"><span style="font-family: calibri, sans-serif; font-size: 12pt;"><strong><span style="color: black;">About B. Braun </span></strong></span></p><p style="margin-bottom: .0001pt;"><span style="font-family: calibri, sans-serif; color: black; font-size: 12pt;"> </span></p><p style="margin: 0px;"><span style="font-family: calibri, sans-serif; color: black; font-size: 12pt;">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<sup></sup> and CAPS<sup></sup>.</span></p><p style="margin-bottom: .0001pt;"> </p><p style="margin-bottom: .0001pt;"><span style="font-family: calibri, sans-serif; font-size: 12pt;"><span style="color: black;">Globally, the B. Braun Group of Companies employs more than 61,000 employees in 64 countries. Guided by its Sharing Expertise<sup></sup> 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 </span><u><span style="color: blue;"><a href="http://www.bbraunusa.com/" target="_blank" rel="noopener">www.BBraunUSA.com</a></span></u><span style="color: black;">.</span></span></p><br /><br /><b>Responsibilities</b><br/><br <p style="margin: 0px;"><span style="font-family: calibri, sans-serif; font-size: 12pt; color: #000000;"><strong>Position Summary:</strong></span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: calibri, sans-serif; font-size: 12pt; color: #000000;">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 policies and procedures, FDA Regulations, ISO Standards and Canadian Medical Device Regulations, where applicable.</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: calibri, sans-serif; font-size: 12pt; color: #000000;"><strong>Responsibilities: Essential Duties</strong></span></p><ul><li style="color: #1f497d;"><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">Supervises employees, tasks and duties related to quality control within organization. </span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">Develops, implements and assesses processes and policies designed to test products and services. </span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">Monitors and evaluates current testing processes, making recommendations for improvements when necessary.</span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">Understands and enforces quality, regulatory and safety compliance as related to the company procedures and law.</span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">Conducts visual and physical inspections of company products and materials. </span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">Monitors the performance of the quality control staff, ensuring that the quality control department meets organizational objectives.</span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">Responsible for personnel actions including (but not limited to) hiring, performance management and termination.</span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">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.</span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">Plan, recommend and coordinate testing of manufactured or purchased products.</span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">Review, investigate, report and assist in the identification of product nonconformances. Assist with corrective actions to preclude the recurrence of similar issues.</span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">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. </span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">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.</span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">Troubleshoot problems with QC testing equipment and assurance to calibration standards.</span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">Provide support to the functional groups within the company on quality control inspection techniques. </span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">Assure efficient and economical utilization of materials and continuous improvement of methods to eliminate wasteful practices within the functional group.</span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">Identify and implement quality system improvements when gaps are identified through audits and departmental reviews.</span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">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.</span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">Ensure personal training in accordance with department training matrix.</span></li><li style="color: #1f497d;"><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">Provide input to budget development and ensure operations within approved department budget. Actively contribute to cost control methods.</span></li><li style="color: #1f497d;"><span style="color: #000000; font-size: 12pt; font-family: calibri, sans-serif;">Experience and/or understanding of injection molding processes producing componentry and final machine assembly. </span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">Performs other related duties as required by management.</span></li></ul><p style="margin: 0px;"><span style="font-family: calibri, sans-serif; font-size: 12pt; color: #000000;">The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.<br /> <br />General:<br />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." </span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: calibri, sans-serif; font-size: 12pt; color: #000000;"><strong>Expertise: Knowledge & Skills</strong></span></p><ul><li><span style="color: #000000; font-size: 12pt; font-family: calibri, sans-serif;">Operational experience and knowledge of quality policies, FDA Regulations and ISO Standards for medical device or pharmaceutical operations. </span></li><li><span style="color: #000000; font-size: 12pt; font-family: calibri, sans-serif;">Investigative, root cause analysis (RCA) and problem solving experience for nonconformances/deviations in paper based and/or electronic systems.</span></li><li><span style="color: #000000; font-size: 12pt; font-family: calibri, sans-serif;">Experience and ability in leading a multifunctional material review board (MRB) team for product disposition.</span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">Advanced knowledge of quality control inspection techniques. Ability to apply statistical techniques and quality tools.</span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">Must be able to work with all functional groups.</span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">Excellent verbal and written communication skills.</span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">Strong attention to detail and accurate record keeping.</span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">Strong organization abilities and problem-solving skills</span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">Ability to work in a team environment.</span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">Advanced computer skills including a word processing, and spreadsheet / data tracking analysis.</span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">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.</span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">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.</span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">Judgement is required in resolving complex problems based on experience.</span></li><li><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">Contacts are primarily with department supervisors, leads, subordinates, and peers. Frequent contact with external contractors/vendors.</span></li></ul><p style="margin: 0px;"><span style="font-family: calibri, sans-serif; color: #000000; font-size: 12pt;">Required:</span></p><ul><li><span style="color: #000000; font-size: 12pt; font-family: calibri, sans-serif;">Prior Quality experience or combination of Quality and Manufacturing.</span></li></ul> <img src="https://analytics.click2apply.net/v/j7VaV7hjn5EAfRZ6ulN6R"> <br/><br/><br /><b>Qualifications</b><br/><br /><p style="margin: 0px;"><span style="font-family: calibri,sans-serif; font-size: 12pt;"><strong>Expertise: Qualifications -Education/Experience/Training/Etc</strong></span></p><p style="margin: 0px;"><span style="font-family: calibri,sans-serif; font-size: 12pt;"><strong> </strong></span></p><p style="margin: 0px;"><span style="font-family: calibri,sans-serif; font-size: 12pt;"><strong>Required:</strong></span></p><ul><li><span style="font-family: calibri,sans-serif; font-size: 12pt;">Bachelor's degree required.</span></li><li><span style="font-family: calibri,sans-serif; font-size: 12pt;">04-06 years related experience required.</span></li><li><span style="font-family: calibri,sans-serif; font-size: 12pt;">Applicable industry/professional certification preferred.</span></li><li><span style="font-family: calibri,sans-serif; font-size: 12pt;">Regular and predictable attendance</span></li><li><span style="font-family: calibri,sans-serif; font-size: 12pt;">Secrecy and invention agreement and non-compete agreement, Ability to work non-standard schedule as needed</span></li></ul><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: calibri,sans-serif; font-size: 12pt;">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.</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: calibri,sans-serif; font-size: 12pt;">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.</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: calibri,sans-serif; font-size: 12pt;">Through its Sharing Expertise initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.</span></p><p style="margin: 0px;"> </p><p>PI119340138</p>

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Posted: 2020-03-25 Expires: 2020-04-25

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Supervisor II, Quality Control

Allentown Mfg Facility
Allentown, PA 18109

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