QA EXECUTIVE

Wear Safe (Malaysia) Sdn Bhd; Klang City; On-site; MYR 40,000 - 60,000; Full time

Job summary

A medical device manufacturing company in Klang City is seeking a Quality Assurance professional to oversee the preparation of quality documents and ensure compliance with regulations such as ISO 13485 and FDA. Candidates should have a Bachelor's degree in a relevant field and at least 2 years of experience in quality assurance within a regulated environment. Strong communication skills and the ability to work independently are essential. This role involves liaising with various departments and participating in audits to maintain high quality standards.

Qualifications

• Minimum 2 years working experience in related field.
• Knowledge and experience in medical device regulations, validation, audit, risk management.
• Familiarity with ISO 9001 and ISO 13485 quality management systems.

Responsibilities

• Preparation of all Quality Document associated with the manufacture of medical devices.
• Interface with other departments for quality document preparation.
• Assist in internal and external audits and compile data for management reviews.

Skills

Good written and oral communication skills

Good analytical and problem-solving skills

Ability to work independently

Time management

Strong computer skills

Education

Bachelor’s Degree in Science/Chemical Engineering/Mechanical Engineering/Chemistry or equivalent

Job description

Responsible for preparation of all Quality Document associated with the manufacture of medical devices to ensure compliance with ISO 13485, ISO 9001, cGMP, FDA and MDR guidelines.

Interface with other departments to compile and determine the required content of quality document for preparation of production Technical File, product specification, device master record and other Quality document.

New artwork packaging design review to comply all applicable with EC Council Directives, FDA and other international regulations.

Assists in establishing, reviewing and / or updating company’s Procedures and Work Instructions.

Assists in the preparation, coordinating and handling the internal and external audits.

Assists in compiling data and quality trends for management reviews.

Assists in compiling and providing the documentation on product registration and any other Marketing request.

To arrange, preparation and document the product shelf life study in accordance to the international standards.

To observe the company policy.

To follow the company safety rules and regulations in daily operation.

To assist the Head of Section, RA/QA and to recommend objectives and strategies including short and long term plans in the implementation and coordination of the Company’s policies on GMP with the view to maximize Quality Assurance and adherence to International Standards at all times and that the Company’s Standards are never compromised.

Provide in-process QC quality improvement and provide support for other QA activities in SPC and GMP.

Supervise daily duties of the QA Supervisors.

Participate in management decisions on Company’s policies and practices pertaining to the Company's Quality Assurance.

Planning, implementing and maintaining quality improvement programmes and encouraging personnel to contribute and actively participate in these programmes.

Liaise with manufacturing personnel and production executive on specifications, complaints, quality problems etc in addressing corrective/preventive action for continuous improvement.

Participate in the implementation of the company’s social accountability compliance.

Other assigned duties as required by his/her superior.

Qualification

Minimum Bachelor’s Degree in Science /Chemical Engineering/ Mechanical Engineering/Chemistry or equivalent.

Experience

Minimum 2 years working experience in related field.

Knowledge and experience in medical device regulations, validation, audit, risk management, ISO 9001 and ISO 13485 quality management systems, cGMP and FDA in a regulated environment.

Other Personal Capabilities

Good discipline and attitude, proactive and good initiatives.

Good written and oral communication skills

Good interpersonal skills.

Good analytical, problem-solving skills and decision making.

Good observant, truthful, sincere and honest.

Ability to manage, result orientated, have good time management and resourceful.

Ability to work independently with minimum supervision.

Ability to exceptional listening, and presentation skills.

Ability to work well with people at all levels of the organization.

Strong computer skills are preferred.

Knowledge in products inspection and test.