Sr Supplier Quality Engineer - Hazelwood, United States - BioFire Diagnostics
Description
Position Summary
Ensure products and services received from suppliers meet the quality standards of bioMerieux. Work closely with Suppliers, Global Purchasing, Supply Chain, Industrialization, Manufacturing and Engineering in the execution of the supplier quality program. Provide quality support in the areas of SCAR management, supplier change control, supplier management, and supplier qualification to ensure compliance with the FDA and other regulatory requirements.
Primary Duties
+ Perform all work in compliance with company quality procedures and standards.
+ Maintain compliance of Supplier Quality System elements applicable to the Site/Function (Supplier Audits, Focused Audits, Supplier Quality Management, Supplier Change Control)
+ Manage relationships and key metrics for suppliers.
+ Participate in regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of supplier quality.
+ Create and manage the supplier audit program including; audit plan, scheduling, audit execution, writing audit report and follow up on corrective actions as needed.
+ Monitor supplier performance and report Quality Indicator data during appropriate Supplier Steering Committee meetings.
+ Issue Supplier Non-Conformance documents as needed, tracks responses, and verifies corrective actions.
+ Act as Principle Quality contact at Supplier Steering Committee meetings and Business Reviews providing information and metrics.
+ Act as Change Review Board participant and Quality reviewer/approver for change management activities.
+ Manage supplier change notifications by tracking, evaluating, and coordinating (when necessary) technical assessments, drawing/document updates and SAP updates due to supplier changes.
+ Obtain Supplier Quality Agreements when applicable.
+ Participate and provide guidance for Supplier change checklist process.
+ Provide supplier quality metrics as needed for company meetings (including weekly, monthly, quarterly and QSMR).
+ Assist with the approval / disapproval of suppliers, including collaboration with the purchasing group on supplier leveling and
+ Support continuous improvement projects.
+ Conduct and/or approve investigations as needed (NCs and CAPAs)
Qualifications
Training and Education
Requires a Bachelors degree in a scientific field.
Experience
Requires a minimum of 4 years related experience with competence in the selection and use of Quality Engineering Tools and Techniques and experience in auditing
Must have experience as an internal auditor
Knowledge, Skills, and Abilities
+ Requires strong computer skills in Microsoft Office Package (Excel, Word, etc.).
+ Must possess strong written and verbal communication skills.
+ Must have a knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO, QSR, UL, CSA, VDE, etc.).
+ Certification in one of the following is highly desired: CQE, CSQE, CRE, CQA, CBA, or Six Sigma Green Belt.
Working Conditions and Physical Requirements
+ Ability to wear PPE correctly most of the day.
+ Domestic travel required 20% of time
+ International travel required <5 % of time
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