Job Description:
Quality Assurance Strategist Role
As a key member of our quality assurance team, you will ensure that we deliver high-quality products on time and in compliance with established standards and regulations.
* Manage product quality or compliance for a portfolio of external contract manufacturers and suppliers.
* Assess the quality of external suppliers' products, processes, and related documents to ensure product specifications are met and quality systems are maintained.
* Support internal and external partners with auditing activities related to quality assurance activities or contractor audits.
* Support onboarding activities of new contractors or product launches within the portfolio.
* Makes product quality decisions leveraging comprehensive knowledge of Quality/Manufacturing principles, prior work experience, and concepts in other technical areas while ensuring compliance to global regulatory requirements.
You will have the ability to influence quality decision-making in line with industry requirements. Identify, develop, and implement continuous improvement initiatives related to quality assurance processes to ensure compliance with the latest internal and external standards.
Ensure adequate tracking and documentation of all required quality-related actions in relevant system(s) and follow escalation processes as needed.
Lead and support complex investigations/risk assessments in support of products within your portfolio.
This role requires strong technical writing skills, verbal, written communication, and presentation skills. You must be able to work independently with minimal supervision, interact with high levels of management at contractors and within our organization, and build/maintain relationships with key stakeholders both internally and externally.