- 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 (, 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.
- Bachelor's 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 writing and communication in Bahasa Malaysia and English.
- Work hours flexibility
- International environment
- A growing team with good spirit
- Competitive total rewards
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QMS Engineer - Santa Rosa Jáuregui, México - Avery Dennison Smartrac
Descripción
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 $ billion. Learn more at .
Job Description
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:
Qualifications
Additional Information
We not only embrace change... we drive it. We work hard, push hard, and take brave risks. Our culture is innovative and collaborative - where bold ideas turn into action. We grow strong talent through stretch opportunities only restricted by your interests. We are committed to workplace diversity, both for employees and for the business. We are a force for good, embedded in industries and communities worldwide. We are challenging ourselves and others to reach higher and think bigger to improve the quality of all life. Avery Dennison is a great place to work for everyone. We offer:
Avery Dennison is an equal opportunity employer. If you are interested in knowing more about our Diversity & Inclusion approach, please go to
Please let us know if we can support you with reasonable accommodations throughout the application process by contacting our Talent Acquisition team via
