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(Senior) Manager, Global Quality

atma.io

atma.io

Quality Assurance
Querétaro, Mexico
Posted on Wednesday, June 19, 2024

Company Description

About Avery Dennison

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 34,000 employees in more than 50 countries. Our reported sales in 2023 were $8.4 billion. Learn more at www.averydennison.com.

Job Description

WHAT YOU’LL BE DOING:

Quality Assurance (QA)

  • Manage Quality System development and compliance within all Operations Facilities globally; ensuring all records are always ready for inspection.

  • Interface with clients on establishing, developing, finalizing, and documenting all related Quality requirements (Product attributes); and represent the ‘Voice of Client’ (VoC) to describe the stated and unstated qualitative client needs or requirements to internal teams. VoC may be captured via direct discussion or interviews, surveys, client specifications, observations, warranty data, field reports, etc.

  • 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.

  • Create and maintain necessary Design / Process FMEAs and associated Quality Control Plans (QCP) to achieve consistent Manufacturing superiority for all CtQs (Ppk > 1.6).

  • Regularly evaluate and upgrade both Product and Service provision by Operations, clearly identifying Client Musts, Wants, and Wows (Kano model of perception vs reality).

  • Engage clients re: Technical / Quality reviews; and support Commercial requests, while communicating and managing Stakeholders to achieve business goals, objectives, and the overall Quality Strategy.

  • Ensure all client complaints and quality-related issues originating from Suppliers, Internal Production, and at Client applications are responded to timely; with validated effective CAPA plans.

  • Drive Continuous Improvement initiatives within Ops to achieve competitive benchmark.

  • Drive business efficiency, effectiveness, innovation, and cooperation across entities, leveraging heavily on the QMS (SOPs / WIs) for globalization and standardization.

Risk Management

  • Lead the effort in compliance activities to CSRs, Standards, and Regulatory requirements (where appropriate).

  • Assess, Analyse, 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.

  • Function as reviewer and key approver for specific industry SOPs / WIs / validation documentation; and all Engineering Change requests to ensure modifications are effective and in-line with client and industry expectations, in close collaboration with Development Quality where needed.

  • Provide operational guidance and support to issue resolution, product quality/risk assessment and product disposition. Provide support in new product development, design transfer and related validation. Provide solutions-oriented communication to clients on complaints and various quality topics.

  • Establish strong Supplier accountability via traceable specifications E2E, with Procurement / Engineering / Supplier Quality Management so that all identified risks are clearly made accountable.

  • Monitor, report, and escalate to senior management any inconsistencies or concerns between industry requirements, risks, and CSRs appropriately.

  • Advise on any AD generic SOPs meeting ISO 9001, ISO 14001, and ISO 45001 that may conflict specific industry requirements and actively drive to reconcile gaps.

Qualifications

WHAT YOU WILL NEED TO BRING TO THE TEAM:

Avery Dennison has a long history of being a market leader. Your history is also important to us. It should include the following attributes, especially for the Healthcare / Medical industry:

  • Show broad knowledge and demonstrating experience in managing client / regulatory inspections is a must.

  • In-depth experience in negotiating client contracts (Quality part).

  • Have a clear understanding of continuous improvement methodologies, and adopt a structured approach where required.

  • Experienced in providing clear traceability (and auditing thereof) of all Client Specific Requirements CSRs via cross-referencing contracts, standards, SOPs, WIs, checklists, and records.

  • An expert in the application of Quality tools especially FMEA / QCP / 8D / 3x5why. Able to articulate and explain methodologies related to process control ie SPC and Ppk.

  • Able to engage clients independently to build a strong reputation and relationship to showcase best-in-class quality approaches of AD.

  • Articulate a generic understanding of ISO13485 and FDA CFR 21 part 820 requirements.

  • Good appreciation of GMP / GDP concepts.

  • Proven experience in risk assessment and project management.

  • Demonstrated hands-on experience in conducting Verification and Validation (V&V) work, including directing IQ, OQ, and PQ activities at the factory.

  • Be self-driven, positive attitude, be able to cope with tight deadlines, and adapt to shifting priorities.

  • Have excellent interpersonal communication skills to interact effectively with various stakeholders including Global Quality sub-functions and Factory Quality leaders.

  • Strong command of spoken and written English.

  • Good analytical skills to review data, formulate written analysis; and a keen attention to detail to spot any remaining risks.

  • Ability to provide clear direction and coaching to Site Quality team members, to deliver positive results and strong collaboration.

  • Exhibit analytical, critical-thinking, and problem-solving skills to review systems, find flaws, and pose solutions.

  • Ability to handle stress; operate under deadlines independently or as part of a team, while still meeting standards.

  • Willing and available to travel (globally).

Credentials

  • 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.

  • A 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 VDA6.3 standard is a plus.

  • Experience and knowledge with international standards e.g. ISO9001, IATF 16949 / related core tools, ISO 13485, 21 CFR part 820.

  • 6 Sigma DMAIC Black belt certified preferred.

Additional Information

Who we are! - Our Story:

Every voice. Every day! Eight Values. One Team!

Being open to every voice, every day, brings our value of diversity to life and makes Avery Dennison a vibrant and engaging place to be. We understand diversity and equal opportunities as enrichment for our future-oriented work. Across our diverse, global team, every voice makes us stronger. When we listen to and learn from each other, there is no limit to what we can achieve together. Each of us is unique, and we appreciate bringing together different personalities and talents.

Avery Dennison is an equal-opportunity employer.

To find out more about all our employee resources groups globally as well as our Diversity, Equity & Inclusion approach, please go to https://www.averydennison.com/en/home/about-us/diversity-and-inclusion.html