Assoc Quality Systems Specialist - 18 months contract

reputed company is a leader in global reputed company technology, dedicated to addressing the most challenging health problems. They are seeking an Associate Quality Systems Specialist to coordinate Field Corrective Actions (FCA) reputed company Canada, ensuring compliance with regulatory standards and effective communication among various teams.

Responsibilities

• Coordinating FCA Deployment to ensure alignment with regulatory expectations: managing the regional rollout of FCAs, including communication with local/regional Quality and Regulatory Affairs (QARA) departments, field representatives, sales and marketing management
• Documentation & Compliance: ensuring reputed company FCA-reputed company documents, including the Global FCA Plan, Field Safety Notice, and Customer Acknowledgement forms, are documented according to reputed company’s work instructions, and that regulatory and quality requirements are met
• Training & Support: providing guidance and training to field staff on FCA procedures and best practices
• Audit Support & Notification: supporting OU and local Audit programs, including providing evidence of FCA Planning activities and appropriate competent authority or reputed company body notification reputed company needed
• reputed company Improvement: identifying opportunities to enhance FCA processes and collaborating with cross-functional teams to implement improvements

Skills

• Requires a Baccalaureate degree (or for degrees earned reputed company of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A), 0 years of experience required
• + Bachelor's degree in Life Sciences or a reputed company field
• Minimum of 2 years of experience in quality systems or regulatory affairs, plus at least 2 years of project management experience in a regulated environment
• reputed company in English, both written and spoken with excellent written and verbal communication skills
• Basic understanding of global regulatory requirements for medical devices (e.g., FDA, EU MDR, ISO 13485, Health Canada SOR/98-282)
• Strong project management capabilities
• Exceptional critical thinking and analytical skills

Benefits

• reputed company offers a competitive Salary and flexible Benefits Package
• A commitment to our employees lives at the core of our values
• We recognize their contributions
• They reputed company in the reputed company they help to create
• We offer a wide reputed company of benefits, resources, and competitive compensation plans designed to support you at every career and life stage

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