To supervise the QC inspections (IQC, IPQC, OQC) in all areas to ensure an effective and efficient job meeting product quality and delivery requirements.
Assist the QMR in performing quality control and improvement in production.
Assist the QMR in all in-process quality feedback analysis and follow-up actions to responsible process/production engineers.
Approve in-process quality checks for production lines.
Collect in-process samples, create reports on test results, both internal and external, and generate Certificate of Analysis (COA).
Knowledgeable in verification of material and product defects at incoming materials inspection, in-process inspection, final inspection, and proper lot disposition.
Develop and update procedures, maintain and review all QMS procedures, and conduct staff training for both new and existing staff.
Conduct quality investigations in collaboration with the quality and production team.
Ensure all laboratory & production equipment are calibrated, in repair, and consumables are replenished.
Perform daily warehouse organization, receiving, quality assurance, inventory control, space management, logistics, floor productivity, shipping, and customer service.
Audit and report warehouse inventory, checking critical material stock levels and identifying minimum order quantity (MOQ) of materials.
Request for quotation (RFQ) from suppliers, preparation of purchase orders, maintaining and updating the supplier list and contact information.
To develop and perform equipment qualification and validation - Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
To develop and review facility Good Manufacturing Practices (GMP) requirements, implement GMP procedures, and confirm compliance is met.
To perform design for manufacturing/Design for assembly (DFM/DFA) evaluation, material and process control evaluation and qualification, product verification and validation.
To communicate with internal stakeholders, equipment suppliers, vendors, external customers, and third-party auditors.
To provide production documentation such as production reports, procedures, specifications, drawings, visual aids, and work instructions
Ad hoc tasks as per job requirements.
Degree in Mechanical / Electronic / Electrical / Manufacturing Engineering or relevant disciplines,
3-5 years of working experience in project management, production and quality,
Experience in optics and medical device manufacturing is an advantage,
Good command of spoken and written English, Cantonese & Putonghua,
Understand and comply with quality standards (ex.ISO9001, ISO13485, GMP) working attitude,
Knowledge in systematic manufacturing engineering,
Well-versed in MS office application,
Mature, strong sense of responsibility & able to work under pressure,
Team player with well developed interpersonal skills,