Primary Job Function: The Quality Assurance Engineer will coordinate the implementation and maintenance of the Quality Management System (QMS), conduct audits, drive process improvements, and manage supplier and customer relationships to guarantee the reliability and compliance of the supply chain. Your Tasks * Ensure strict adherence to ISO 13485 standards, conduct audits, and oversee corrective/preventive actions. Maintain, update, and review quality documentation, ensuring alignment with ISO 13485 requirements. This includes quality manuals, procedures, work instructions, and records. * Conduct regular internal audits to assess compliance with ISO 13485 standards. Collaborate with external auditors during certification and surveillance audits. * Facilitate and oversee the implementation of CAPA processes, ensuring timely resolution of non-conformities and preventive actions to mitigate risks. * Develop, implement, and continually improve the QMS to meet industry and regulatory requirements. Conduct risk assessments and drive enhancements. Continuously review and update procedures to align with best practices and regulatory changes. * Audit suppliers, establish quality criteria, and nurture collaborative relationships to ensure high-quality materials and/or services. Collaborate closely with customers to resolve quality issues, drive improvements, and establish mutually beneficial relationships to enhance overall supply chain quality. * Identify and implement improvements within the organization utilizing data-driven approaches. * Training & Development: Develop training programs and collaborate cross-functionally to embed a quality-focused culture.our Profile Your Profile * Bachelor’s degree preferred. * 4 + years’ experience of quality experience preferred. * Previous experience with ISO 13485 required. * Prior experience developing key performance indicators (KPIs) and metrics to monitor the effectiveness of quality processes. * CAPA Development. * Control of documents We Offer * Medical, Dental, Vision, Life Insurance, and Disability Pay. * 401(k) with company matching up to 6%. * Paid Time Off, including paid holidays. * Flexible Spending Accounts. * Voluntary benefits such as legal and financial assistance, pet insurance, and more. * Employee Assistance Program. * Ongoing employee development opportunities, including tuition reimbursement, scholarships, and training. * Commuter benefits. * Employee engagement activities. EOE Protected Veterans/Disability