QMS Engineer

At Transitions Optical we help people live more vibrant lives by enhancing their vision and the way they perceive light.

We are the manufacturer of Transitions ® eyeglass lenses, the world's leading photochromic lens. Transitions ® lenses automatically adapt to changing light. They darken outdoors and return back to clear when you come inside.

Our talented people make significant advances in color science and lens materials, setting new standards of advanced performance to provide ever increasing visual comfort and optimum harmful blue light protection, and always blocking 100% of UVA and UVB rays.

Product leadership, consumer focus, and operational excellence have made Transitions ® lenses one of the most recognized brands in optics.

Transitions Optical is part of EssilorLuxottica, a global leader in the design, manufacture and distribution of ophthalmic lenses, frames and sunglasses.

Position: QMS Engineer

Location: Transitions Optical, Amata, Chonburi

Reporting Manager:  Quality Section Manager

The purpose of this position is to ensure TOTL’s conformance to regulatory bodies for ISO13485.  The incumbent will also be responsible in the certification and recertification processes of different regulatory bodies. Maintain and improve the Quality System.

KEY RESPONSIBILITIES:

• Identifies, manages and controls documents that are included and related to the different regulatory bodies.

• Conducts periodic Internal Quality Audits to verify whether the quality activities comply with the set procedures, and whether these procedures are implemented effectively and are suitable to achieve the objectives set.

• Prepares and disseminates the necessary documentation that will implement and maintain the quality system.

• Ensures continuous maintenance, translation and updating of the Quality Standards.

• Implements and continuously improves the quality system within the company in accordance with the regulatory bodies’ requirements.

• Prepares the meeting agenda and minutes as instructed by the QMR and distributes copies to the attending associates.

• Manages the Opportunity for Improvement (OFI) system to ensure raised issues are closed within the specified time.  The incumbent also validates the implementation and effectiveness of both corrective and preventive actions formulated to ensure consistent conformance to the established system.

• Coordinates with concerned process validation teams ensuring minor and major process changes conform to the quality plan and set requirements including enhancing all the employees to have a Quality mindset.

• Works as internal audit team leader that is responsible for

  • Develops and administers the internal audit plan/schedule

  • Prepares Audit Planning Sheet and notify concerned process owner.

  • Reviews audit reports generated by the audit team as necessary prior discussion to Manager or Process Owner.

  • Submits a completed internal audit report to the management for incorporation in the management review.

  • Updates the procedure as necessary.

  • Takes charge in all the phases of the audit and conducts opening/closing meetings.

  • Analyzes non-conformances seen during the audit and recommend system or process improvements when necessary.

  • Prepares necessary internal audit reports and generates corrective action requests (OFI) for non-conformances and opportunities for improvement.

• Leading Risk management / Promote Quality awareness to employee

• Promotes and maintains a safe and healthy work environment.

• Performs other duties as requested.

PRE-REQUISITES/QUALIFICATION:

• Bachelor's degree in Science and/or Engineering.

• At least 3-5 years experience in a manufacturing industry as a QMR or Quality Systems coordinator.

• With adept knowledge in Quality Cost Concepts and techniques.

• Very familiar with ISO 9001 and or ISO 13485 standards, regulation and using various tools and techniques to examine, question, evaluate, and report

• Above average written communication skills.

• Speaking & written English is a must.

• With leadership skills and understanding of human factors and motivation

• An intermediate (or better) proficiency with Word, Excel, PowerPoint is required.

Desire:

• Frequent communications with multiple department personnel within TOTL.

• Coordination with QMS Certifying Bodies.

PERSONAL CHARACTERISTICS:

• Strong interpersonal and communication skills.

• Develop and maintain a good level of staff morale.

• “Hands on” commitment to achieving goals and planned objectives.

• Willingness to seek advice when required.

• Team focused.

• Highly motivated, flexible attitude, self-starting person.

• Ability to work on flexible and extended hours as required.

• Creative thinker – Transitions encourages employees to contribute ideas.

• Maintain the image of the company to fellow employees, community and industry as a whole.

• Can work with multitasking system control and is a good coordinator.