Supplier Quality Engineer

Job Description

Position Overview

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.

 

Responsibilities

Conduct 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 place.

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%

Job ID: 183058

Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Inc.

Experience Level: Mid-level Professional

Job Type: Full-time



Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.

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