QA Technician

QA Technician

Responsibilities:

• Work together with the Quality team to establish the quality control methodology and system to ensure the high-quality operations.
• Assist in the completion of ISO 13485 certification.
• Perform in-process and final inspections and define appropriate inspection and acceptance criteria.
• Plan and coordinate quality control program designed to ensure continuous production of products consistent with established standards
• Actively assure operational observance to compliance obligations to include, regulatory, contractual, and SOP driven requirements.
• Develop and initiate standards and methods for inspection, testing, and evaluation.
• Monitor and maintain site Quality Metrics (includes customer satisfaction interaction).
• Develop and review documentation for regulatory appropriateness, correctness and organizational effectiveness.
• Apply total quality management tools and approaches to analytical and reporting processes.
• Design and implement quality control training programs
• Ensure management and control of non-conforming material/product process.

Preferred Qualifications:

• Proven track record with implementation, maintenance of Quality Management Systems (ISO 13485).
• 1-3 years Quality Leadership experience in the medical devices or pharmaceutical manufacturing industry
• Experience in a fast-paced manufacturing environment is preferred
• Knowledge of quality systems, ISO 13485, and regulatory knowledge for medical devices and/or pharmaceutical manufacturing
• Proven track record with implementation, maintenance of Quality Management Systems (i.e. ISO 9001, ISO 13485, ISO 22000, etc.) is an asset
• Familiarity with federal regulations concerning pharmaceutical products and/or medical device regulatory requirements
• Ability to evaluate scientific/technical information from a Quality perspective.
• Knowledge and experience in risk management, tolerance studies, product reliability and safety assessments
• Well-organized, multi-task oriented and efficient
• Effective communication skills
• High energy, self-motivated, and attention to detail
• Works well independently and as part of a team     

Location: Markham, ON