Supplier Quality Engineer III

Company: B. Braun Medical
Location: Irvine
Posted on: January 25, 2023

Job Description:

B. Braun Medical, Inc.

Supplier Quality Engineer III

US-CA-Irvine

Job ID: 2022-21956
Type: Regular Full-Time
# of Openings: 1
Category: Quality
Irvine Facility

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 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 .

Responsibilities

Position Summary:
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 audit.
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 responsibility area,
Respond to customers as needed (account management - supplier quality agreements, questionnaires, customer specifications, data analysis, etc.).
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 manager.
Develop, collect and analyze Quality metrics relating to supplier quality.
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 standards.
Works closely with cross functional teams, including product design, product management and production, to identify and mitigate quality risks.
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 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 action
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 operation.
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. 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 experience.
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 levels
Good documentation, communication, and interpersonal relationship skills, including negotiating and relationship management skills
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 environment
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 relationships
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 electronic database

Qualifications

Expertise: Qualifications -Education/Experience/Training/Etc

Required:
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.

Additional Information

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:Reaching upward and downward, Push/pull
Frequently:Stand, Sit
Constantly:N/A
Activities:
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, Walking
Constantly:N/A
Environmental Conditions:
Occasionally:Proximity to moving parts
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:Office environment, Production/manufacturing environment, Warehouse environment, Lab environment
Frequently:N/A
Constantly:N/A

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 www.bbraunusa.com.

Through its Sharing Expertise - initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

Notices

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.

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Keywords: B. Braun Medical, Irvine , Supplier Quality Engineer III, Engineering , Irvine, California