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Conduct periodic audits to verify that process capability requirements are maintained over the time.
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Also, responsible for conducting supplier audits to ensure that documented process flow is followed, and necessary process controls are in place.
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Drive resolution of quality issues back to the supplier. This includes customer complaints and non-conformances.
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Ensure they are informed of and aligned around quality issue resolution.
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Update supplier quality metrics for monthly reviews. Report on all supplier quality-related activities to assure fulfillment of requirements.
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Participate in supplier design/engineering review & approval process, and New Product Introduction processes.
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Support supplier selections and evaluations including determining the degree of supplier control necessary to establish compliance, based on the significance of product being purchased.
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Provides Supplier Quality guidance within the Supplier Quality Assurance group to contribute and support key functions such as: Engineering, Manufacturing, and Procurement groups.
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Identify systemic supplier quality issues and driving corrective and preventative actions through:
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Primarily intra organizational contacts and external contacts.
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Provides specialized guidance or train support and/or professional staff. Leadership qualities and role model qualities demonstrated.
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Engineering, Mechanical Engineering, Chemistry, Biochemistry or related field.
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Must have 3-5 years’ experience in a Supplier Quality Engineering role for a medical device or pharmaceutical company.
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Typically 8-10 years of successful experience in related field.
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Understanding of FDA regulations, ISO13485, EU IVDD/IVDR.
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Travel is required for this position: potentially 20 – 30%.