Job Description

Company Description

ABOUT AVERY DENNISON:

Avery Dennison (NYSE: AVY) is a global materials science company specializing in the design and manufacture of a wide variety of labeling and functional materials. The company\xe2\x80\x99s products, which are used in nearly every major industry, include pressure-sensitive materials for labels and graphic applications; tapes and other bonding solutions for industrial, medical, and retail applications; tags, labels and embellishments for apparel; and radio frequency identification (RFID) solutions serving retail apparel and other markets. Headquartered in Glendale, California, the company employs more than 32,000 employees in over 50 countries. Learn more at

ABOUT AVERY DENNISON SMARTRAC:

Built on a legacy of innovation and materials science, Avery Dennison has embarked on a new era of opportunity. This is an opportunity to take the functional and traditional label and enable it with digital technologies that can give every item a unique digital identity and digital life.

This \xe2\x80\x9cintelligence applied\xe2\x80\x9d technology has the capability to enable a world of connected everything. A world where the \'who, what and where\' of every physical, become points of irrefutable fact and absolute visibility. Provenance, authenticity, sourcing, history, real-time location; guaranteed for businesses and consumers throughout the entire supply chain and all the way to the home. At its most simple, a company with a legacy in \xe2\x80\x9cmaking labels\xe2\x80\x9d becomes a category-leading technology company making the Internet of Things a positive, transformative, world-wide reality for all of us. The label has always told us something about the product. Now it can tell us everything.

In February 2020, Avery Dennison acquired Smartrac, a leading manufacturer of RFID products. Integrated within the Intelligent Labels business, we view our combined potential as limitless. Collectively, our deep industry knowledge and expertise in technology and innovation, R&D, quality and service serve to drive RFID and technology adoption across multiple industries. By standing on the shoulders of today, we walk taller into tomorrow - and we take those steps together, as pioneers, in a future we may share and positively determine. And we want you to be part of our journey!



Your role:

To oversee factory QMS Documented Information specifically for Medical requirements. Interact and liaise with customer and external certification body auditors for the factory auditing program. Assist to create, monitor, and improve ISO 13485 and 21 CFR 820 quality system procedures to ensure compliance requirements are met efficiently and effectively and in support of company objectives.

Activities may include but not limited to:

Quality assurance support in the design and development of medical device products, facilitating the application of design/change controls, risk management, quality plan, and implementation of design and development plan.

Act as SME for key subsystems such as Design Control, Risk Management, Design Verification, Design Validation, Process Validation, etc.

Provides QA support for internal Quality System Growth.

Implements and maintains quality systems, policies, and procedures that ensure compliance with ISO 13485, cGMP, FDA (i.e., 21 CFR part 11, 21 CFR part 803, 21 CFR part 806, 21 CFR part 20) and other applicable standards.

Provide Quality oversight of internal and external process characterization project plans, protocols, and reports.

Activities to include authoring, issuance, and review of regulated documents and ensure processes and products comply with current Good Manufacturing Practices and 21 CFR 820.

Support regulatory inspections by FDA and foreign regulatory agencies.

Making recommendations to the Quality Director for improvements in policy and procedures.

To lead Document Controllers to ensure effective implementation of document and data control.

To initiate Management Review Meeting schedule and establish an internal audit plan/schedule.

To follow up audit corrective action reports and track for effective closure.

To lead a group of internal auditors to carry out Quality System Audit to ensure compliance with the ISO13485 requirements and others.

Qualifications

• Bachelor\xe2\x80\x99s Degree in any disciplinary or equivalent.
• At least three (3) years of working experience in related fields and familiarization in ISO9001, ISO14001, and ISO13485 manufacturing environments.
• Demonstrated experience in creating and documenting IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) reporting.
• Deep knowledge in ISO13485 & dGMP & FDA.
• Knowledge of cGMP and FDA regulations.
• Good audit and problem-solving skills.
• Strong experience in QA Plan, control, maintain and monitor quality management system and meet all related regulatory requirements.
• Proactive in applying knowledge, to forecast needs of the medical client / industry.
• Able to work well in a matrixed environment.
• Able to work independently with minimal supervision.
• Excellent communication and presentation skills. Good written and communication in Bahasa Malaysia and English.

Additional Information

All your information will be kept confidential according to EEO guidelines.

Avery Dennison