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SUMMARY: Provides Quality Engineering leadership and support to ensure product quality, safety, and compliance with regulatory requirements. Decisions and recommendations made by this position directly impact the quality of marketed products for domestic and international sales. All successful candidates will work within 21CFR820, and EN ISO13485 (including applicable regional and sub-ISO standards). Additional regulations and standards may apply.  DUTIES AND RESPONSIBILITIES: Maintains compliance with standards and regulations (QSR, ISO 13485, ISO 14971) and drives improvements in Quality System elements. Executes elements of the quality system, which may include: Complaint process including customer interface, investigation, MDR reporting determination, record keeping and follow-up. Technical review of drawings, inspection plans and procedures, Change Notice documentation. Reporting statistical information and trend analysis on Quality Data Leads quality/process improvement initiatives and participates in internal auditing. Works with established written procedures.       Participates in writing, changing, and training on procedures.   Performs supplier audits and works with suppliers to assure quality of incoming materials Serves on product development teams and performs and/or advises on key design control activities for new or changed product, including risk management through the product life cycle, statistical and technical suitability of verification/validation protocols and acceptance criteria. requirements traceability through verification and validation. Performs failure investigations of products, processes and systems. Implements corrective and preventive action projects as assigned by management. Up to 25% Travel. Other duties as assigned.QUALIFICATIONS:   Bachelor’s degree in Engineering or related technical field Four years medical device experience or an engineering role in a similar regulated environment. ASQ Certified Quality Engineer preferred. ASQ Certified Quality/Biomedical Auditor desired. Six Sigma certification desired.  COMPETENCIES: Strong communication skills with the ability to effectively present information and respond to questions from managers, coworkers, and customers. Strong technical writing, troubleshooting and problem-solving skills. Ability to work effectively and professionally in collaborative team settings. Proficient with standard business software including Microsoft Word, Excel, Access, and PowerPoint. Ability to read and understand engineering drawings in English. Proficient in statistical data analysis and presentation Experience in regulated systems including 21CFR820, ISO13485, etc. is required. Self-directed and proactive individual with a healthy sense of urgency and drive for results.         PHYSICAL DEMANDS: The employee is regularly required to sit, stand, walk, and reach with hands and arms. Must be able to perform in a normal office environment requiring sitting at a desk and using a computer. Specific vision abilities required by this job include close vision and color vision.    Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Melakukan tugas utama nya sebagai operator produksi Mampu melakukan pekerjaan sebagai seorang operator produksi Mempunyai kemampuan mengoperasikan mesin produksi Memahami kerja dengan standart (K3) Keamanan,kesehatan dan keselamatan kerja Kualifikasi Pria dan Wanita usia 18 - 24 tahun Lulusan minimal SMK/SMA /sederajat (Semua Jurusan) Tidak bertatto atau bertindik Non pengalaman/baru lulus/Fresh graduate di persilahkan melamar Tidak sedang terikat kontrak kerja dengan perusahaan lain Informasi Tambahan Gaji pokok UMR Lemburan,Insentif BPJS ketenagakerjaan Bukan yayasan  

SUMMARY: As part of the Operations Team, this position is responsible for technically managing existing products and transitioning new products into Operations. Duties include but are not limited to: assisting in or leading component sourcing, working with vendors on technical issues, evaluating and procuring assembly equipment, designing and building fixtures and test equipment, conducting test method validations, validating processes, writing and training assembly instructions and providing clear records of such activities as established in procedures, protocols and other objectives.  Performs job functions in accordance with company QSP, Financial, and Safety Procedures. All successful candidates will work within 21CFR820, ISO (including applicable regional and sub-ISO standards) and Sarbanes Oxley compliant systems. Additional regulations and standards may apply.  DUTIES AND RESPONSIBILITIES: Develop and implement Operations procedures, processes and technological solutions to meet product line cost targets for existing products. Partner with Product Development to do the same for new products. Write and conduct (as appropriate) Work Instructions, PM Plans, Engineering Studies, qualifications and process validations (IQ, OQ, PQ). and Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. Use statistical techniques to measure, evaluate, and optimize raw components, assemblies, finished goods and operations processes (GR&R, SPC, Capability analysis, DOE, etc). Manage Non-Conforming Material Reports (NCMRs), Corrective and Preventive Actions (CAPAs) and aid in complaint investigations from beginning to end. Participate in lean manufacturing initiatives Update drawings, specifications, procedures, literature, etc, through Change Control methods. Partner with Quality to ensure all manufacturing deliverables comply with Encision’s QMS. Develop and conduct preventive maintenance and calibration of equipment as required. Travel as needed to conduct the duties and responsibilities identified. Level of travel is expected to be low.  QUALIFICATIONS: A Bachelors of Science in Engineering, preferably in Mechanical or Industrial Engineering 5+ years’ experience in medical device manufacturing under 21CFR820 and ISO13485 Applied statistics training and experience Solid Works training and experience Work with minimum oversight Ability to develop expertise in relevant medical device legal and regulatory requirements, as defined in the Encision Quality Manual, is required. Ability to read and comprehend instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations, all in English. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of the organization (as appropriate) in English.  COMPETENCIES: Healthy sense of urgency Effective time management, task and priority prioritization Excellent problem solving skills from initiation to completion Ability to weigh costs vs. benefits of methodologies and solutions Expert Microsoft Word and Excel skills Work with minimal supervision Expertise in relevant medical device legal and regulatory requirements, as defined in the Encision Quality Manual, is required. Ability to read and comprehend instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations, all in English. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of the organization (as appropriate) in English.           PHYSICAL DEMANDS: The employee is regularly required to sit, stand, walk, and reach with hands and arms, use hands to finger, handle, feel, and be able to talk, and hear. Specific vision abilities required by this job include close vision, color vision and ability to adjust focus. The employee is frequently required to lift and/or move up to 50 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.