Supplier Quality Engineer III
Company: B. Braun Medical
Posted on: November 25, 2022
B. Braun Medical, Inc.
Supplier Quality Engineer III
Job ID: 6
Type: Regular Full-Time
# of Openings: 1
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 .
The Supplier Quality Engineer is responsible for the overall
supplier management program including supplier audits and
conducting internal audits. Apply knowledge of quality engineering
principles and methods to ensure compliance with regulatory
requirements and the company's Quality Systems to optimize
manufacturing and distribution.
Responsibilities: Essential Duties
- Establishes quality standards for incoming materials including
supplier and receiving inspection Test method validation in
compliance with the Companies QMS requirements.
- Ensure material qualification methods of suppliers are aligned
with standards, global regulations, and industry best
- Responsible for tracking internal and supplier audit schedule,
scheduling audit, executing audit, reporting, and closing out
- Lead internal audits to ensure the effective implementation of
the Quality Management System.
- Perform audits of Quality Systems and Processes at suppliers of
materials, components, sub-assemblies, and services.
- Assess non-conformances/audit findings and leads closure of
supplier actions as needed.
- Draft supplier quality agreements. Work with suppliers to
ensure quality system requirements are understood and successfully
met. Manage supplier notification of changes and supplier
- Manage SCARs (Supplier Corrective Action Request) within
product responsibility area,
- Respond to customers as needed (account management - supplier
quality agreements, questionnaires, customer specifications, data
- Utilize statistical techniques and six sigma tools to analyze
processes and drive continuous improvement activities. Support
process and quality system improvement projects as assigned by the
- Develop, collect and analyze Quality metrics relating to
- Communicate supplier quality risks to management or internal
teams during reviews and project meetings, and identify solutions
to mitigate risks.
- Coordinate suppliers and verify supplier quality standards are
in accordance with Company's requirements.
- Track and qualify or disqualify suppliers according to company
- Works closely with cross functional teams, including product
design, product management and production, to identify and mitigate
- Audits production processes, raw materials or suppliers/vendors
to ensure that established quality standards are met.
- Conducts root cause analysis for defects, non conformities or
other quality failures.
- May be responsible for ensuring compliance with formal external
quality standards, such as ISO 9001.
- Define supplier qualification requirements for incoming
materials including supplier and receiving inspection Test method
validation in compliance with Companies' QMS requirements.
- Supplier Audits: Plan, Execute, and document Supplier
- Monitors supplier quality performance by tracking product
defects, delivery failures and other recorded incidents involving
he supplier's failure to meet requirements and recommend corrective
- Maintain successful relationships with procurement,
engineering, manufacturing and regulatory departments
- Partners with problem suppliers to identify root cause of
quality issues and ensures timely corrective action is taken to
secure continuity of supply.
- Serves as liaison with vendors for supply chain, suggests
structural quality and process improvements, and collaborates with
other engineers in a team environment
- Lead and assist in supplier management initiatives.
- Aide manufacturing in the evaluation and qualification of new
supplier materials following a defined Company process
- Evaluates suppliers' internal functions to assess their overall
performance and provides feedback in the assessment of their
- QA approvals for Engineering Change Notices, test methods, and
test equipment to assure the design and production of medical
devices are in compliance with applicable standards.
- Ranks & prioritizes suppliers for supplier quality improvements
and partners with supplier personnel to improve suppliers' internal
process The job function listed is not exhaustive and shall also
include any responsibilities as assigned by the Supervisor from
time to time.
It shall be the duty of every employee while at work to take
reasonable care for safety and health of himself/herself and other
Expertise: Knowledge & Skills
- Requires full working knowledge of relevant business practices
and procedures in professional field.
- Uses standard theories, principles and concepts and integrates
them to propose a course of action.
- Work under minimal supervision. Relies on experience and
judgement to plan and accomplish assigned goals.
- May periodically assist in orienting, training, and/or
reviewing the work of peers.
- Judgement is required in resolving complex problems based on
- Contacts are primarily with department supervisors, leads,
subordinates, and peers.
- Occasional contact with external contractors/vendors.
- Required Knowledge Quality Engineering principles
- Validation principles, statistical tools, and good knowledge of
Supplier Corrective Action Report (SCAR) / CAPA is required
- 2-3 years as a Lead Auditor preferred
- Ability to interact professionally with all organizational
- Good documentation, communication, and interpersonal
relationship skills, including negotiating and relationship
- Strong problem-solving, organizational, analytical, and
critical thinking skills
- Able to speak and present information in front of groups, both
internally and externally
- Knowledge of and adherence to Quality systems
- Ability to manage competing priorities in a fast-paced
- Must be able to work in a team environment, including the
ability to manage suppliers and project stakeholders
- Ability to build productive internal/external working
- Attention to detail, and regulatory and policy
- Effective interpersonal skills
- Verbal/written communication skills
- Knowledge with process and product validation and
- Good computer skills in usage of MS Office Suite and other
Expertise: Qualifications -Education/Experience/Training/Etc
- Bachelor's degree required.
- 06-08 years related experience required.
- Applicable industry/professional certification preferred.
- Regular and predictable attendance
- Occasional business travel required, 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.
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.
While performing the duties of this job, the employee is expected
- 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:
Keywords: B. Braun Medical, Irvine , Supplier Quality Engineer III, Professions , Irvine, California
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