Job Description:
Quality Assurance Expertise
We are seeking a Quality Assurance expert to develop and refine our global quality systems policies and procedures for new product development.
The ideal candidate will have the ability to interpret standards, regulations, and guidance documents to tailor these needs into systems that meet requirements and offer a usable approach.
* Develop effective solutions capable of meeting global needs.
* Maintain an understanding of applicable standards, regulations, and guidance documents affecting Design Controls, Process Development, and Risk Management.
The successful candidate will work closely with cross-functional teams to implement global policies and procedures, ensuring consistency across the organization.
Responsibilities:
* Develop and maintain an understanding of relevant standards, regulations, and guidance documents.
* Coordinate implementation of global policies and procedures with local sites and functional stakeholders.
* Support the development and deployment of training programs, using smart approaches with worked examples.
* Represent the company in internal/external audits and act on assigned audit responses/CAPAs.
* Monitor CAPAs and internal/external audit feedback from manufacturing operations entities' quality systems and evaluate impacts to global policies and procedures.
* Drive consistency across the organization in approaches to Design Controls, Process Development, and Risk Management.
* Maintain a culture of ethics and compliance by recognizing, demonstrating, and enforcing appropriate behavior.
* Ensure all quality, regulatory, compliance, and product-specific requirements are met.