ISO13485 Expert

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ISO13485 Expert

@ ASH Industries

Position Description:

• Manages the Document Control function and supports the Quality Assurance and Regulatory Affairs functions in accordance with quality system procedures.

Responsibilities/daily tasks:

• Surface grinding, manual milling, precision fitting
• Document Control Duties
  • Maintains master document control system via the Document Change Order (DCO) process. Ensures timely DCO review, approval, incorporation, checking, and release.
  • Administers the project document control system to support new product development activities.
  • Maintains external document control system to ensure that all external documents referenced in controlled documents are available.
  • Prepares and revises controlled documents in accordance with standard formats. Document types include specifications, procedures, forms, plans, protocols, and reports.
  • Coordinates product information language translations with outside services.
  • Maintains various lists, logs and tracking systems related to documents and records.
  • Releases approved documents including copying, stamping, and distribution. Retrieves superseded and obsolete document revisions to prevent inadvertent use.
  • Archives, organizes, and secures various quality records including Design History Files, Device History Records, and Quality System Records to provide for reliable and efficient retrieval.
  • Identifies training requirements related to new/revised procedures and coordinates training completion. Maintains procedure training matrices to ensure that personnel training requirements are defined, training accomplishments are documented, and appropriate corrective actions are taken.
  • Manages electronic files in secure manner to prevent unauthorized changes. Coordinates backups of electronic files to ensure recovery of lost data.
  • Performs comprehensive document reviews to verify completeness of Device Master Records and generates status reports. Works with contract manufacturers to ensure the proper transfer of company requirements into the contractor’s Device Master Records.
• Quality Assurance Duties
  • Administers equipment calibration and maintenance system, environmental monitoring program, and product bioburden monitoring program, including coordination of subcontracted services
  • Inspects products in accordance with written procedures, statistical sampling plans, engineering drawings and specifications as assigned. Documents nonconforming products as appropriate.
  • Coordinates nonconforming product reviews to efficiently disposition affected products.
  • Maintains quality system logs, records and filing systems.
  • Maintains and operates inspection and test equipment.
  • Provides input regarding inspection methods and quality procedures.
  • Ensures traceability of components and products.
  • Facilitates the timely completion of corrective and preventive actions.
  • Assists with supplier evaluations and performance monitoring
• General Duties and Responsibilities
  • Establishes and maintains quality system procedures related to areas of responsibility.
  • Advises and trains other Company personnel concerning areas of responsibility.
  • Ensures appropriate communication processes are established within and across functional groups.
  • Communicates information related to quality management system effectiveness.
  • Represents areas of responsibility in internal and external quality audits.
  • Assists with corrective and preventive action planning and implementation.
  • Works in accordance with quality system procedures.

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Qualifications:

Qualifications Required:

• High School diploma or equivalent certification.
• Minimum five (5) years’ experience in Quality Assurance/Control or Document Control in a manufacturing environment; medical device industry preferred.
• Proficient with word processing, spreadsheet, presentation and document management software.
• Languages: Full professional proficiency in English is minimum requirement.

Preferred:

• Background in maintaining an ISO 13485 quality system
• Experience using internet cloud storage services.
• Experience in reading and interpreting engineering drawing, specifications, and statistical sampling plans.
• Experience using dimensional/visual inspection equipment including microscopes.
• Good hand/eye coordination, manual dexterity, color vision, and visual acuity (corrected if necessary).
• Ability to work well under pressure and to meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other people.
• Ability to work in a highly detailed environment where mental focus and accuracy of work output is essential.
• Good organizational and oral and written communication skills, including ability to represent the Company to both internal and external audiences.

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How to Apply:

Apply online at https://ashindustries.com/about-us/join-the-team. 

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