QA Engineering Technician 2

Summary:

We are seeking a quality technician who able to work in fast-paced environment. Performs functions associated with quality control and quality assurance operations and play a crucial role in ensuring the quality and compliance of our manufacturing processes is well maintained. This position involves nonconformance event processing and analysis, internal/ external audit support, quality documentation review and processing, and collaborating with cross functional team to maintain product quality and integrity. May assist in developing methods and procedures for quality assurance and control.

Essential Duties and Responsibilities:

• Supports quality engineering activities such as change order processing, nonconformance event processing and handling (Exp: NCMR, out of tolerance, excursion, etc), execution/ verification of validation protocols
• Collects data and conducts inspections in the manufacturing process from receiving inspection to product release to support investigations led by Quality Engineers.
• Support production through more presence on manufacturing line and support inspection team with questions related to methods or processes.
• May support Quality Engineering with compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six Sigma).
• Update and maintain quality assurance protocols and methods for processing materials into partially finished or finished products.
• Responsible to ensure compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standards requirements for worldwide distribution.
• Support and works on Nonconformance reports including work with cross functional team in nonconformance event assessment, QA verification, material disposition.

• Performs regular line audit to ensure systems comply with requirements and are effective.
• To provide assistance and support to the Quality Engineering and Operations function in day-to-day production quality issues and implement correction/ corrective action.
• Identify opportunities for process/ quality improvement and contribute to continuous improvement initiatives to enhance product quality/ process efficiency.
• Communicates any concerns about work process regarding environmental impact, health or safety issues to their manager.
• Able to reads and understands specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools.

• Able to reviews and interpret engineering drawing and specification.
• Decision making ability coupled with the ability to work on one’s own initiative and with minimum supervision is required.
• May assist in training and mentoring junior technician.
• Applies intermediate computer skills in the use of Microsoft Office.
• Excellent attention to detail.
• Assumes and performs other duties as assigned

Required Qualifications:

• Candidate must possess at least Diploma or equivalent and minimum 2-5 years of related experience. Proven experience in a quality control or related role within manufacturing environment are preferred.
• Medical Device experience preferred. Some knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality management systems) will be added advantage.
• Adopts hand on approach and able to perform shift duties.
• Proficient in Microsoft office application knowledge.

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