Company Description

Avery Dennison Corporation (NYSE: AVY) is a global materials science and digital identification solutions company that provides a wide range of branding and information solutions that optimize labor and supply chain efficiency, reduce waste, advance sustainability, circularity and transparency, and better connect brands and consumers. Our products and solutions include labeling and functional materials, radio frequency identification (RFID) inlays and tags, software applications that connect the physical and digital, and a variety of products and solutions that enhance branded packaging and carry or display information that improves the customer experience. Serving an array of industries worldwide — including home and personal care, apparel, general retail, e-commerce, logistics, food and grocery, pharmaceuticals and automotive — we employ approximately 35,000 employees in more than 50 countries. Our reported sales in 2023 were $8.4 billion. Learn more at www.averydennison.com.

Avery Dennison is an equal opportunity employer.
Please let us know if we can support you with reasonable accommodations throughout the application process by contacting our team via [email protected]

Job Description

You will manage the quality function by providing work direction for quality engineers and inspectors and interact regularly with engineering, manufacturing and service functions to establish quality standards for raw material, work in process and finished products.

Primary Responsibilities and Essential Job Functions:

• Formulate a strategy to foster a high performance culture with quality right first time suitable for a world class medical device contract and legal manufacturer.
• Lead and motivate a large team with strong quality assurance, quality control, stakeholder partnership, risk assessment and mitigation. Benchmark and implement best practice. Foster programs around best practice, risk mitigation, proactive problem solving, innovation, clear autonomy, delegation and clear responsibility with structures fit for purpose, individual and team development and succession planning.
  • Plan and strategise for systems and procedure evolution commensurate with growth plans and identify for future requirements.
• Drive improvements to the quality system that ensures its suitability, adequacy, and effectiveness.
• Understand and ensure compliance with cGMP, ISO 13485, and FDA 21 CFR Part 820 regulations.
• Work closely with commercial and operations to build value with top 10 key accounts and engage with customer quality representatives directly. Implement strategies and tactics to drive short, medium and longterm innovation and improvement plans in the relentless pursuit of zero defects.
• Provide operational support related to defining accurate problem statements, issue resolution and problem solving, product quality/risk assessment, and product disposition.
• Assist in the investigation of non-conformances as required.
• Conduct, coordinate and review investigation of product complaints and assignment of root cause determinations when required. Determines if complaints require regulatory affairs involvement for adverse event evaluation.
• Provide QA support in the review and approval of plant related validation protocols, reports, and change requests. Support Project Management Office in timely pursuit of progression of priority activities.
• Provide facility quality support and representation in new product development, scale up, design transfer, and facility validation activities.
• Represent quality and/or regulatory on core design change and new product development teams to ensure the design control process is followed effectively.
• Participate in the ISO 13485 certification process and regulatory inspection.
• Provide support in customer, supplier, and regulatory audits.
• Maintain quality systems and provide support for specific sections of the quality system as assigned.
• Develop and conduct training related to quality system and regulatory requirements.
• Develop quality SOPs to ensure compliance.
• Adopt key enablers such as best practice, automation and ICT platforms that drive efficiency and improvements.

Qualifications

• Bachelor’s degree in Engineering or scientific related field.
• A minimum of 4 years of experience in the medical device or pharmaceutical industry with at least 3 years of experience in regulatory compliance and quality systems.
• At least 4 years of experience in managing a team
• Thorough knowledge of ISO 13485 and 21CFR Part 820.
• Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA) and/or Certified Manager of Quality/Operational Excellence (CMQ/OE).
• Experience handling multiple responsibilities with minimal direction.
• Strong written and verbal communication skills; strong presentation skills.
• Able to effectively work with various functions and levels within the organization.

Additional Information

We offer:

• Competitive salary, company pension, and health insurance allowance
• Financial support with relocation
• Structured learning and development
• Mentoring program

We do not accept unsolicited referrals or resumes from any source other than directly from candidates.