Quality Engineer (Medical Background)

Full Time
Kulim
Posted
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’s 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 www.averydennison.com


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 “intelligence applied” 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 “making labels” 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!


Job Description
  • To develop and implement procedures as required by the standards and regulatory requirements for process and product control to ensure product and process validation are in compliance with cGMP, FDA 21 CFR Part 820 and ISO 13485.
  • Providing guidance and training on documentation of process control, validation documents, change control.
  • Evaluating the process and risk assessment and determine the quality and control plan.
  • Monitoring the process and product quality with applicable quality tools.
  • To troubleshoot and propose corrective and preventive action plans.
  • To lead or support improvement projects as necessary.
  • Any other tasks or projects that are being assigned by the immediate supervisor, as and when required.

Qualifications
  • Possess at least Degree in Science or Engineering with working experience in Healthcare, Pharmaceutical, Life Science, Medical Device industry and etc.
  • Minimum 3 years of experience in a Quality systems related environment. Candidates with experience in the Medical Device or Pharma industry will be preferred.
  • Solid understanding of Quality Management System and certified in Quality System ISO 13485.
  • Good understanding of regulatory requirements especially for medical devices with excellent communication skills.
  • Good interpersonal skills. Strong quality mindset. Ability to manage conflicting situations.
  • Strong English communication skill (both verbal & written).

Additional Information


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

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