Position Summary & Responsibilities:
Support quality programs to develop, implement, and continually improve systems to ensure customer requirements are implemented into the Company products and services. Support operations compliance with government regulations (FDA, Canadian Medical Device Registration, IVD Directive and other applicable regulations) and all other applicable standards (ISO, etc.). Lead Change Control efforts for Product Labeling.
- Perform analysis for Drug Component Specification revisions impacting VITEK 2 AST Product Labeling.
- Track VITEK 2 AST Product Labeling modifications and coordinate with Product Labeling & Documentation to prepare for implementation.
- Initiate and process change requests related to the life cycle management of VITEK 2 AST and Identification Product Labeling Deliverables.
- Lead and support assessments of the quality systems for compliance (e.g. customers, FDA, ISO Registrars), and ensure that such assessments are conducted in accordance with established policies and procedures to maximize their benefit.
- Participate in teams to accomplish deliverables, milestones, and objectives to meet plans and schedules by ensuring that any changes to the plans are communicated and agreed to by teams and project sponsors for the St. Louis site. This includes standardizing processes at the site to ensure the North America ISO 9001 & 13485 and MDSAP registration is maintained.
- Participate in the Corrective and Preventive Action programs to lead process, product and service improvements related to the Quality System.
- Support the site by ensuring relevant documentation meets the requirements of 21CFRPart 820 Quality System Regulation, In-Vitro Diagnostic Directive and other country specific regulatory requirements.
- Participate in site or external auditing processes as necessary
- Manage site compliance projects as needed
- Lead, author, and/or facilitate root cause investigations.
Education, Skills, & Experience:
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Bachelor's degree in a scientific field with 3+ years of experience in Quality Engineering, Quality Control, or Quality Systems required.
- Master's degree with 1+ year of experience in Quality Engineering, Quality Control, or Quality Systems required also accepted
- Requires 1+ year progressively responsible quality systems experience in a relevant industry (such as medical device).
- Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
- Must have expert knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO, QSR, UL, CSA, VDE, etc.).
- Must possess strong interpersonal, written and oral communication skills.
- Certification in one of the following is preferred: CQE, CQA, CBA, CMQ/OE, or Six Sigma Black Belt.
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