Global Quality Assurance Manager
hace 14 horas
About the Role:
Avery Dennison Smartrac is seeking a highly skilled and experienced Quality Assurance professional to join our team as a Global Quality Assurance Manager. In this role, you will be responsible for managing the development and implementation of quality systems across all operations facilities globally, ensuring compliance with regulatory requirements and industry standards.
Key Responsibilities:
- Develop and maintain quality systems, processes, and procedures to ensure compliance with regulatory requirements and industry standards.
- Interface with clients to establish, develop, and finalize quality requirements, and represent the 'Voice of Client' to internal teams.
- Create and maintain a systematic Quality Function Deployment (QFD) of client/product requirements, and translate them into specific quantitative plans to enable product & process design/development, and manufacture of products that effectively and efficiently meet those needs.
- Document Requirements Traceability and clearly mapping to supporting evidence, so that product quality as defined by the client is clearly linked throughout the development/manufacturing process; and into the finished product.
- Lead the effort in compliance activities to CSRs, Standards, and Regulatory requirements (where appropriate).
- Assess, Analyze, and Document all Risks and actively develop strategies for risk elimination/mitigation; constantly driving best practices across the organisation.
- Lead best practices internal audits to achieve GDP / GMP (including at external Suppliers), and drive improvements to achieve zero Major Non-Conformances.
- Provide operational guidance and support to issue resolution, product quality/risk assessment and product disposition.
Requirements:
- A recognized bachelor's degree, in Electronics and/or Electrical Engineering (Semiconductors preferred).
- Minimum 10 years of working experience within QA, with 7 years in the Healthcare industry.
- Clear understanding of how to navigate a matrixed organisation with min 5yrs as a people manager.
- Certified Lead auditor to ISO13485 with a proven record of auditing global Suppliers.
- Experience in auditing to standard is a plus.
- Experience and knowledge with international standards ISO9001, IATF 16949 / related core tools, ISO 13485, 21 CFR part 820.
- 6 Sigma DMAIC Black belt certified preferred.
About Avery Dennison Smartrac:
Avery Dennison Smartrac is a global leader in the development and production of inlay and tag products for the RFID industry. We are committed to delivering high-quality products and services that meet the needs of our customers. Our team is passionate about innovation, quality, and customer satisfaction.
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