Be part of something bigger at BD. Here, you’ll help us continually improve how we do things every day; to be more efficient, more effective and better serve our customers. You’ll do this within an exceptional team all striving to make sure that everything we do complies with regulations and standards, not just because it’s the right thing to do, but because our products impact people’s quality of life. Here, you’ll put your compliance experience, high expectations and attention to detail to the very best use: advancing the world of health™. At BD, you can make a true difference of one.
Job Description SummaryThe Supplier Quality Engineer manages the supplier quality program ensuring that suppliers deliver quality parts, materials, and services. The SQE implements and maintains a comprehensive supplier management system to ensure that incoming materials comply with specifications. The SQE collaborates with suppliers to resolve quality issues and validate/verify supplier changes.
The essential functions of this position include but are not limited to:
- Work will include providing management of suppliers internal to BD as well as external suppliers.
- Works closely with Production, Material Control, and other departments to ensure all supplier quality and supplier management activities are being met.
- Maintains familiarity with manufacturing processes and products to evaluate the cause and effect of incoming material defects.
- Coordinate the disposition of rejected materials with material control and suppliers.
- Maintain supplier relationships and initiate actions to provide required supplier quality performance.
- Conduct supplier audits and coordinates other assessments/surveys.
- Maintains accuracy and completeness of all Supplier Files and the Approved Supplier List (ASL)
- Communicates specification changes to suppliers and coordinates Supplier Change Requests
- Works with Canaan suppliers (Internal and External) to implement Supplier Quality Agreements
- Acts as a resource to work groups and project teams, within the plant and outside the plant relative to quality and regulatory issues.
- Supports and/or leads projects using continuous improvement tools and methodologies.
- Maintains and communicates supplier quality metrics.
- Works with engineering teams to define process parameters and criteria to ensure supplier process capability is effective to meet product and process requirements.
- Oversees the work assignments and activities of QA incoming inspection personnel.
- Oversees incoming raw material inspections, raw material release and maintenance of buy specifications and process documentation related to supplied materials.
- May be engaged in evaluating, selecting, validating, and qualifying equipment, tools, technologies, etc. to assure accurate inspection.
Other responsibilities of this position include but are not limited to:
- Complies with, and responsible for enforcing, all local, state, federal and BD safety regulations, policies/procedures.
- Complies with all local BD quality policies/procedures/practices through consistent application of sound Quality Assurance principles. Ensures compliance through appropriate communication, training, and education of sound Quality Assurance principles. Responsible for the activities and programs as defined for this position in the Quality Systems Manual - BD Canaan.
- Performs other job-related duties as assigned.
- Observes and reinforces all safety, environmental and quality system standards.
- Controls activities within his/her scope of control, such that departmental budgets are met. Contribute information as required to establish departmental budgets.
- Be familiar with plant and divisional goals and develop standards of performance that will contribute to the accomplishments of those goals.
EDUCATION, EXPERIENCE AND SKILLS
- B.S. or B.A. Degree in Science-related field, Quality Assurance, Engineering, Mathematics/Statistics or equivalent.
- Certified Quality Auditor highly desirable.
- Prior auditing experience, preferred.
- Prior supervisory experience desired.
- Working knowledge of Validations, IQ, OQ, PQ, and DOE's is desirable.
- Proven track record of supporting and driving continuous improvement activities in a production environment.
- Prior experience working in the Medical Device field is a plus.
- Prior experience with ISO 13485:2016 and or applicable regulations is preferred.
Physical Requirements Level 2
Light Work: Exerting up to 20 pounds occasionally, and/or 10 pounds of force frequently, or negligible constantly. Walking or standing to a significant degree or sitting constantly and pushing/pulling controls.
Strong verbal, written, analytical, persuasion and interpersonal skills. Working knowledge of computers. Organizational skills required. Ability to accept responsibility and perform duties with little or no direct supervision. Strong understanding in the use/application of statistics.
Ability to operate personal computer, statistical software, precision measuring equipment and office equipment.
The position is subject to inside environmental conditions typically associated with an office environment and plant manufacturing exposure.
Some Travel may be required: up to ~25% travel.
Although primarily a first shift position, may require working additional hours as needed to support the business.
This position reports directly to the Applicable Quality Manager
This position has supervisory responsibilities for Quality incoming inspection.
Adjust verbiage as needed with how much travel is required for the position
Primary Work LocationUSA CT - Canaan
Work ShiftUS BD 1st Shift 8am-5pm (United States of America)
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Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
BD is unique in how fully dedicated it is to a specific disease state. It makes it clear how the work we do directly impacts the daily lives of the patients we serve.
Senior Director Quality Management
To know that our products touch 30 million people with diabetes around the globe is powerful and fuels our teams to deliver best in class products to them each and every day.
It is inspiring to see BD products to be used globally to advance human healthcare.
Manager Medical Laboratory