Quality Lead I

RXinsider LTD.; Irvine (CA); On-site; USD 42,000 - 50,000; Full time

Job summary

B. Braun Medical Inc. is seeking a Quality Lead I to ensure that the label room and chain of custody activities run smoothly, issue materials for production, receive samples from production and issue samples to the labs, and support PM recertification of BU PM inspectors.

The role requires a science background and strong process control to supervise manufacturing quality, provide guidance to staff, and escalate issues as needed to ensure compliance and continuous improvement.

Qualifications

• High school diploma required; Bachelor's degree in a Science related field preferred.
• 04+ years related experience required.
• Ability to work non-standard schedule as needed.
• Regular and predictable on-site attendance.

Responsibilities

• Responsible for performing process monitoring, labeling control, reinspection process monitoring and sampling process for Reserved Samples.
• Provides quality oversight on manufacturing processes to ensure compliance including data integrity.
• Provides routine work direction and training to other Quality Operations Associates.
• Escalates issues to Supervisor as required.
• Provides support for quality investigations and resolution of quality issues.

Skills

Process monitoring

Labeling control

Data integrity

Training others

Quality investigations

Education

High school diploma

Bachelor's degree in a Science related field

Job description

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:

Quality Lead I will ensure that the label room and chain of custody activities run smoothly, which include but not limited to issuing materials for production, receiving samples from production and issuing samples to the labs, and resolving any issues which may arise. Additionally, support PM recertification of BU PM inspectors.

Responsibilities: Essential Duties

• Responsible for performing process monitoring, labeling control, reinspection process monitoring and sampling process for Reserved Samples.


• Provides quality oversight on manufacturing processes to ensure compliance including data integrity.


• Provides routine work direction and training to other Quality Operations Associates.


• Escalates issues to Supervisor as required.


• Provides support for quality investigations and resolution of quality issues.

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

• Please refer to the Corporate Guidelines or BBMUS Guidelines or job specific authorities where applicable. This list is however not exhaustive and may be amended by the Management from time to time.


• Requires working knowledge of technical field/area of specialization. Exercises general application of principles, theories and concepts. Follows established procedures and guidelines.


• Works under general supervision. May periodically assist in orienting, training, assigning & checking the work of other peers.


• May require some limited judgement in resolving problems.


• Contacts are primarily with department supervisors, leads, subordinates, and peers. Occasional contact with external contractors/vendors.

Expertise: Qualifications - Experience/Training/Education/Etc

Required:

• High school diploma required, Bachelor's degree in a Science related field preferred.


• 04+ years related experience required.


• Ability to work non-stand schedule as needed


• Regular and predictable on-site attendance

Schedule Sun-Thurs 9pm - 5:30am

Salary Range: $30.28 - $36.08

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.