Supplier Quality Engineer III
Company: B. Braun Medical
Posted on: January 25, 2023
B. Braun Medical, Inc.
Supplier Quality Engineer III
Job ID: 2022-21956
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 www.BBraunUSA.com .
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 practices.
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 files.
Manage SCARs (Supplier Corrective Action Request) within product
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 supplier
Communicate supplier quality risks to management or internal teams
during reviews and project meetings, and identify solutions to
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
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 Audit
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
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
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 management
Strong problem-solving, organizational, analytical, and critical
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 requirements
Effective interpersonal skills
Verbal/written communication skills
Knowledge with process and product validation and qualification
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:
Occasionally:Reaching upward and downward, Push/pull
Occasionally:Finger feeling, Handling, Hearing - ordinary, fine
distinction, loud (hearing protection required), Push/pull,
Reaching upward and downward
Frequently:Sitting , Standing, Talking - ordinary, loud/quick,
Occasionally:Proximity to moving parts
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
Occasionally:Office environment, Production/manufacturing
environment, Warehouse environment, Lab environment
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
Through its Sharing Expertise - initiative, B. Braun promotes best
practices for continuous improvement of healthcare products and
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.
Keywords: B. Braun Medical, Irvine , Supplier Quality Engineer III, Engineering , Irvine, California
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