Here are the job position details for your review:

Job Title Supplier Quality Engineer 3
Pay Rate: $52 to 56/Hr
Duration: 11 Months
Location: Remote - Candidate willing to work in the EST time zone

This position is for the Healthcare Diagnostics division.

We are looking for a Supplier Quality Engineer supporting medical device manufacturing. This is a remote position, Candidates should be willing to work in the EST time zone

• Supplier Quality Engineer supporting medical device manufacturing.
• Plans organize 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 the 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.

Responsibilities:

• Conduct periodic audits to verify that process capability requirements are maintained over 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/engineering 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 the product being purchased.
• Provides Supplier Quality guidance within the Supplier Quality Assurance group to contribute to and support key functions such as Engineering, Manufacturing, and Procurement groups.
• Identify systemic supplier quality issues and drive corrective and preventative actions through:Primarily intra organizational contacts and external contacts.
• data and information collection regarding trends and issues
• data and information collected from assessments and from the supply base, and
• Root Cause Analysis and Problem Resolution

• Provides procedural support for the engineering organization e.g.: - Creation of quality notifications - Provision, maintenance, and evaluation of processes (e.g. NCR, CAPA), together with the Quality-organization - Planning and execution of design reviews in cooperation with the QMiP - Planning and execution of internal projects (e.g. lean) or events (e.g. CAPA) - ISO 9000 certifications; Quality audits; supplier qualifications. Provides specialized guidance or training support and/or professional staff. Leadership qualities and role model qualities were demonstrated.

Requirements:

• Degree in Engineering, Chemistry, Biochemistry, or related field
• Should have 2-4 yrs' experience in a Supplier Quality Engineering role for a medical device or pharmaceutical company.
• Understanding of FDA regulations, ISO13485, EU IVDD/IVDR.

Job Type: Contract

Salary: $52.00 - $56.00 per hour

Schedule:

• 8 hour shift

Work Location: Remote

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