Supplier Quality Engineer supporting medical device manufacturing.
Plans, organizes and reports on all supplier quality-related
activities to assure fulfillment of requirements.
Participates as part of a geographically dispersed team of Supplier Quality Assurance Engineers and supports global Supplier Quality visions and strategies. Supports development, communication, deployment and management of overall supplier quality strategies
Implement and maintain quality improvement programs and auditing systems with our suppliers. These systems should cover the production processes, quality management and record/documentation management at the supplier.
Work closely with supplier to demonstrate and maintain stable and capable processes, while working at the supplier's manufacturing site. Translate our performance expectations into measurable methods at the supplier. Understand the supplier's current capabilities and potential new capabilities.
Position Reports To: Director, Quality - Supplier Quality. Siemens Healthcare Diagnostics at the Business Area level.
periodic audits to verify that process capability requirements are maintained
over the time. Also, responsible for conducting supplier audits to ensure that
documented process flow is followed and necessary process controls are in
Drive resolution of quality issues back to the supplier. This includes customer complaints and non-conformances. Ensure they are informed of and aligned around quality issue resolution.
Update supplier quality metrics for monthly reviews. Report on all supplier quality-related activities to assure fulfillment of requirements.
Participate in supplier design/eng review & approval process, and New Product Introduction processes.
Support supplier selections and evaluations including determining the degree of supplier control necessary to establish compliance, based on the significance of product being purchased
Provides Supplier Quality guidance within the Supplier Quality Assurance group to contribute and support key functions such as: Engineering, Manufacturing, and Procurement groups.
Identify systemic supplier quality issues and driving corrective and preventative actions through: 1) data and information collection regarding trends and issues 2) data and information collection from assessments and from supply base, and 3) Root Cause Analysis and Problem Resolution Primarily intra organizational contacts and external contacts.
Provides specialized guidance or train support and/or professional staff. Leadership qualities and role model qualities demonstrated.
Required Knowledge/Skills, Education, and Experience
- Engineering, Mechanical Engineering, Chemistry, Biochemistry or related field
- Must have 3-5 yrs experience in a Supplier Quality Engineering role for a medical device or pharmaceutical company. Typically 8-10 years of successful experience in related field
- Understanding of FDA regulations and ISO13485.
- Travel is required for this position: potentially 20 – 30%
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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