招聘：Quality System Manager / 质量体系经理

招聘：Quality System Manager / 质量体系经理

公司类型：医疗器械 公司
工作地点：Richmond, BC
薪资：CAD $65/hour
工作类型：全职
岗位名称：Quality System Manager / 质量体系经理

我们正在招聘一名经验丰富的 Quality System Manager / 质量体系经理 加入公司质量管理团队。理想候选人需具备 5年以上药厂、制药企业或GMP环境下的质量管理相关工作经验，熟悉质量体系、文件管理、偏差处理、CAPA、变更控制、内部审核及合规要求。

该岗位将负责支持和维护公司的质量管理体系，确保公司运营符合相关法规、标准及内部质量要求。我们希望候选人具备较强的质量体系意识、沟通协调能力、文件管理能力及团队管理能力。

主要职责

• 负责维护、执行和持续改进公司质量管理体系；
• 管理和审核质量相关文件，包括 SOP、表格、记录、质量手册及程序文件；
• 负责或协助处理偏差、OOS/OOT、不合格品、CAPA、变更控制及风险评估；
• 组织或支持内部审核、外部审核及供应商审核；
• 确保公司质量活动符合 GMP、ISO 13485 及其他适用法规和标准要求；
• 与生产、研发、注册、采购及管理团队沟通，推动质量流程有效执行；
• 监督质量记录的完整性、准确性和合规性；
• 参与员工质量培训，并推动公司质量文化建设；
• 支持监管检查、客户审核及相关合规准备工作；
• 完成管理层安排的其他质量体系相关工作。

岗位要求

• 本科及以上学历，药学、生物、化学、生命科学、医学、工程、质量管理或相关专业优先；
• 至少 5年以上药厂、制药企业、GMP生产环境或相关质量管理经验；
• 熟悉 GMP、ISO 13485、SOP、CAPA、变更控制、偏差管理、文件控制及质量体系管理；
• 有质量体系管理、审核、法规合规或团队管理经验者优先；
• 具备优秀的文件审核能力、逻辑分析能力和问题解决能力；
• 工作严谨细致，责任心强，能够独立推动质量相关项目；
• 熟练使用 Microsoft Office，包括 Word、Excel、PowerPoint、Outlook 等办公软件。

我们提供

• CAD $65/hour 的有竞争力薪资；
• 参与公司质量体系建设和管理的核心岗位机会；
• 稳定、专业的工作环境；
• 与管理层、生产团队、法规团队及技术团队直接协作的机会；
• 根据个人能力和表现提供长期发展空间。

申请方式

有意者请将简历发送至：info@coswavemedical.com

邮件标题请注明：Application – Quality System Manager – 姓名

我们期待具备药厂质量管理经验、熟悉质量体系，并希望在医疗器械或医药相关行业继续发展的专业人才加入我们的团队。

Hiring: Quality System Manager

Company Type: Medical Device Company
Location: Richmond, BC
Compensation: CAD $65/hour
Job Type: Full-time
Position Title: Quality System Manager

We are looking for an experienced Quality System Manager to join our quality team. The ideal candidate will have 5+ years of quality experience in a pharmaceutical manufacturing company, GMP-regulated environment, or related industry.

This role will be responsible for supporting, maintaining, and continuously improving the company’s quality management system. The successful candidate should have strong knowledge of quality systems, document control, deviation management, CAPA, change control, internal audits, regulatory compliance, and quality operations.

Responsibilities

• Maintain, implement, and continuously improve the company’s quality management system;
• Manage and review quality-related documents, including SOPs, forms, records, quality manuals, and procedures;
• Handle or support deviations, OOS/OOT investigations, non-conformances, CAPA, change control, and risk assessments;
• Organize or support internal audits, external audits, and supplier audits;
• Ensure quality activities comply with GMP, ISO 13485, and other applicable regulatory and quality requirements;
• Work closely with production, R&D, regulatory, purchasing, and management teams to ensure quality processes are properly followed;
• Monitor the completeness, accuracy, and compliance of quality records;
• Participate in employee quality training and support the development of a strong quality culture;
• Support regulatory inspections, customer audits, and compliance preparation activities;
• Complete other quality system-related tasks assigned by management.

Requirements

• Bachelor’s degree or above in pharmacy, biology, chemistry, life sciences, medical sciences, engineering, quality management, or a related field preferred;
• Minimum 5+ years of quality experience in a pharmaceutical manufacturing company, GMP production environment, or related regulated industry;
• Strong understanding of GMP, ISO 13485, SOPs, CAPA, change control, deviation management, document control, and quality management systems;
• Experience in quality system management, audits, regulatory compliance, or team management is preferred;
• Strong document review skills, analytical thinking, and problem-solving abilities;
• Detail-oriented, responsible, and able to independently drive quality-related projects;
• Strong communication skills in English and Mandarin Chinese preferred;
• Proficient in Microsoft Office, including Word, Excel, PowerPoint, and Outlook.

We Offer

• Competitive compensation at CAD $65/hour;
• A key role in managing and improving the company’s quality system;
• A stable and professional work environment;
• Opportunities to work directly with management, production, regulatory, and technical teams;
• Long-term career development opportunities based on performance and capability.

How to Apply

Please send your resume to: info@coswavemedical.com

Email subject: Application – Quality System Manager – Your Name

We welcome experienced quality professionals with a pharmaceutical manufacturing or GMP background who are looking to continue developing their career in the medical device or pharmaceutical-related industry.

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