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Current Openings

Auxein has lots of great opportunities and offers a great work environment, professional development, challenging careers, and competitive compensation

Purchase Manager

Plot No. 169-170, Phase-IV,
Sector-57, Kundli Industrial Area,
HSIIDC, Sonepat-131028,
Haryana, India

  • Import Export experience.
  • Choosing service providers (insurance, logistics, financing etc)
  • Candidate should be from Delhi.
  • Minimum 5-7 year experience.
  • Domestic purchasing experience.
  • Import Export documents knowledge.
  • Multiple suppliers handling
  • Making purchase order
  • Work according to QMS as per ISO 13485:2003.
  • Salary 20-30 K
  • Domestic raw material buying.
  • Import raw material.
  • Import empty boxes aluminum surgical boxes.
  • Machine purchasing CNC and VMC.
  • Machine tools buying from domestic market.
  • Hand Tools buying from domestic market.
  • Store Inventory Audit per month.
  • Supplier Audit yearly.
  • Medical implants purchasing from domestic market.
  • Manufacturing machine oil purchasing.
  • Daily consumables buying.
  • Electrical parts buying.
  • Import Hand Tools.
  • Take quality feedback from user of items from manufacturing operators and staff.
  • Visit freely Gujarat and Mumbai or china or Germany yearly supplier Audits.
  • Purchase master skill required.
  • Stationary buying and checking regularly.
  • Documentation handling experience.
  • Coordinating quality control / good business activities.
  • Preparing the import buying activities (supplier database).
  • Support the buying negotiations.
  • Following up the import buying and domestic buying activities
  • Candidates with Chinese language will be preferred.

Senior Regulatory Affairs Associate

Plot No. 169-170, Phase-IV,
Sector-57, Kundli Industrial Area,
HSIIDC, Sonepat-131028,
Haryana, India

  • 5-8 yrs of working experience in Medical Device Regulatory Affairs
  • Knowledge of MDD 92/42/EEC & 21 CFR, Subchapter H
  • Knowledge of ISO 13485 & 21 CFR 820
  • Knowledge of all applicable medical device directives and FDA regulations on orthopedic implants, external fixators and surgical instruments.
  • Preparation of EU technical files.
  • Preparation of US regulatory submission files
  • Preparation of Clinical Evaluation Reports
  • Role in PMS & PMCF of devices
  • Review Labeling
  • Registration Dossiers and submissions in various countries other than EU region and US.
  • Provide Regulatory review of customer complaints
  • Ensure all regulatory requirement compliance on Design & Development team.
  • Work with regulatory affairs consultants when required.
  • Other duties & responsibilities assigned.
  • Good scientific assessment and writing skills.
  • Competency in medical/regulatory terminology.
  • High level of accuracy and attention to details.
  • Time and project management skills with ability to prioritize tasks.

VMC Programmer Cum Manager (MALE Married)

Plot No. 169-170, Phase-IV,
Sector-57, Kundli Industrial Area,
HSIIDC, Sonepat-131028,
Haryana, India

  • VMC 5 Axis and 7 Axis programming experience minimum 10 years.
  • VMC setting experience.
  • Starting work from operating of machines.
  • Stainless steel cutting experience.
  • Tools and dies molds and fixtures machining experience.
  • 3D designing experience minimum 5 years on UG NX and Solid Works and Cimitron and Power shape.
  • 3D Modeling surfacing and CAD Data and scan data working experience.
  • Programming 5 Axis experience on Power mill and Solid cam.
  • Worker handling experience.
  • Setters Handling.
  • Post processors making experience.
  • First part approval knowledge.
  • Leadership quality.
  • Production Documentation experience.
  • Machine maintenance experience.
  • Quality inspection experience.
  • Renishaw probing experience.
  • Inspection machine CMM and VMM and Profile projector work experience.
  • Reverse engineering experience.
  • Manual Software programing experience only POWER MILL DELCAM and SOLIDCAM.
  • Threading programming experience.
  • 3D scanning reverse engineering experience.
  • Minimum Diploma holder in Mechanical Engineering.
  • Manual Programing G codes.
  • MAZAK control and SIEMENS and HAAS and Fanuc control experience must.
  • Excellent communications skills: interpersonal, listening, oral, and written.
  • Familiar with programming on VMC 5 Axis related to aerospace parts or
  • Ideally located within easy local.
  • Strong background in programming complex 5 Axis details in hard and soft metals.
  • Industry experience – Aerospace (ideal), Nuclear, Medical or Automotive (high end), Motorsport.
  • 5 Axis VMC and 5 Axis CNC mill Programmer- experience must of CNC and VMC SETTER, CNC MACHINIST, Precision Engineering, Aerospace, Military, CNC Mill Turn, DELCAM, Offline Programming…
  • Salary Upto 1,00,000-/

Packing Supervisor

Plot No. 169-170, Phase-IV,
Sector-57, Kundli Industrial Area,
HSIIDC, Sonepat-131028,
Haryana, India

  • Important Medical Device experience.
  • Packing specification knowledge.
  • Batch manufacturing record handling.
  • Incoming experience of packing material.
  • ISO 13485:2012 knowledge.
  • Handling of purchase orders.
  • Rejected material documentation and handling.
  • Cleanroom experience.
  • Air handling unit pressure deferential experience.
  • Magnahalic gauges checking.
  • Manpower handling.
  • Stock maintaining of packing material.
  • Computer knowledge.
  • Supplier Audit experience.
  • Leadership quality.
  • Experience minimum 5 years.
  • Quality Manual System experience.
  • Quality policy and CAPA and change control and non-conformance and inspection material with vernier caliber.
  • Experience must be in medical device packaging area only.
  • Salary upto 30K

Design & Development (Male or Female married) 3 person – Design Engineer

Plot No. 169-170, Phase-IV,
Sector-57, Kundli Industrial Area,
HSIIDC, Sonepat-131028,
Haryana, India

  • VMC 3 Axis programming experience minimum.
  • Starting work from operating of machines.
  • Tools and dies molds and fixtures designing experience.
  • 3D design experience minimum 7-10 years on UG NX and Solid Works and Cimitron and Power shape.
  • 3D Modeling surfacing and CAD Data and scan data working experience.
  • Programming 5 Axis experience.
  • Staff handling experience.
  • Production Documentation and design experience.
  • Quality inspection experience.
  • Inspection machine CMM and VMM and Profile projector work experience.
  • White light or blue light scanning experience.
  • Autocad work experience.
  • Core experience in solid works.
  • Design history file documentation experience.
  • Btech in mechanical minimum.
  • CAPA, PPAP, 5S, Design History File,
  • Revise and update existing drawings reflecting design changes
  • Maintain notes, design calculations and other documentation (like drawings, bill of materials, list of design parameters, and /performance guarantees) for future reference.
  • Works with Director of Engineering on guidelines for installation drawings which meet and exceed the customer’s requirements.
  • Excellent communications skills: interpersonal, listening, oral, and written.
  • Familiar with design parameters related to assembly of auto parts or aerospace parts.
  • ISO 9001:2000 experience.
  • Research pepers reading and searching experience.
  • Responsible to have communication with doctors also for design the parts.
  • Salary: Upto 50K

HR Executive

Plot No. 169-170, Phase-IV,
Sector-57, Kundli Industrial Area,
HSIIDC, Sonepat-131028,
Haryana, India

  • Preparing or updating the Competency Documentas per the Job descriptions developed or modified specifying the standard set of qualification, skills and training required for each designation of the company.
  • Recruitment as per the number of vacancies for different posts as per provided details for qualification needed, experience, skills and other personality traits and salary.
  • After selection, performing the pre-joining & post-joining formalities as per company procedures.
  • Maintaining appropriate records of education, training, skills and experience.
  • Understanding the training needs of the employees by recording the individual needs, departmental needs and organizational needs.
  • Organizing the training in the company premises and filling all the necessary forms of training as per standard operating procedures of company.
  • Preparation of salary sheet of employees after verification of attendance record and to disburse the salary along with the wage slip.
  • Grievance handling of employees.
  • Facing audits conducted by national and international regulatory bodies on behalf of HR department.
  • Perform Cleanliness Check ups and maintaining records.
  • Facilitate employees for Medical Fitness Check-ups before joining or immediately after joining.
  • Maintaining First Aid Kit and Emergency Evacuation Plans
  • Transport Coordination

Assistant Design Engineer

Plot No. 169-170, Phase-IV,
Sector-57, Kundli Industrial Area,
HSIIDC, Sonepat-131028,
Haryana, India

ESSENTIAL JOB DUTIES, RESPONSIBILITIES AND AUTHORITIES:

  • Work on 3D CAD software for creating parts, assembling and drawings on Solidworks.
  • Independent ownership of complete project deliverables, effective communication with cross functional team.
  • Will make 3D Model for die punch, fixture & their assemblies with respective devices.
  • Ensure compliance with Auxein medical internal quality processes and ensure designs/ ideas are complaint with appropriate international standards and guidelines (as above).
  • Any other work assigned by your Reporting Manager.
  • Ensure continual improvement in quality, delivering higher value services and productivity.

Quality Assurance Executive

Plot No. 169-170, Phase-IV,
Sector-57, Kundli Industrial Area,
HSIIDC, Sonepat-131028,
Haryana, India

  • Manage and maintain compliance with the EU market MDD 93/42/EEC directive (including CE Mark applications or self-declarations via technical files) along with Team Head
  • Responsible for maintaining and ensuring that the company quality system meets US FDA, ISO 13485, and all international market medical device requirements.
  • Responsible for ensuring that products and their labeling meet all regulatory requirements (national and international)
  • Responsible for the customer feedback /complaint system
  • Responsible for evaluating rejections and generating the evaluation report.
  • Responsible for working with R&D and manufacturing to develop validation protocols for production processes, and generating the final report covering the validation results and a recommendation for approval or disapproval for the release of the process to manufacturing.
  • Audit Design history files for new products for US FDA/ISO 13485/National Regulatory compliance
  • Responsible for reviewing and establishing the company quality goals each year along with Team Head.
  • Responsible for the Documentation Control Process and Documentation Change Control Process
  • Manage sterilization records and facilitation with contract sterilizer and 3rd party validation processes
  • Responsible for quality control and a quality system for Company’s products and products that we are the legal manufacturer
  • Establish an export compliance system
  • Identifying training and development needs and designing training modules to communicate quality and regulatory requirements.
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