Quality System Specialist

Neptune Medical (NM) is an innovative, seven-year-old, 150+ person VC funded Silicon Valley start-up. NM has commercialized devices in GI Endoscopy, will soon be commercial with breakthrough devices in Cardiovascular, and is working on a grounding Endoluminal Robotics system.

We are looking for a Quality Systems Engineer to join our team who will work with Document Control and Quality Assurance. This candidate will be responsible for managing the Document Control function and supports the Quality Assurance and Regulatory Affairs functions in accordance with quality system procedures.

• Manages activities in areas of responsibility in accordance with quality system procedures.
• Document Control Duties
  • Administers Product Lifecycle Management (PLM) software.
  • 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 documents and standards within 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 but are not limited to 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 Retrieves superseded and obsolete document revisions to prevent inadvertent use.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

• 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.
• Support calibration and preventive maintenance for manufacturing equipment.
• Other duties as assigned.

• High School diploma or equivalent certification.
• Proficient with word processing, spreadsheet, presentation and document management software.
• Product Lifecycle Management (PLM) software experience, e.g., SAP, Windchill, or Arena. Preferred candidates worked with Propel. 
• Languages: Full professional proficiency in English is minimum requirement.

• Experience in Quality Assurance/Control or Document Control in a manufacturing environment; medical device industry preferred.
• 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. 

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, and scanners. Personal Protective Equipment may be required for assigned work. Work may involve lifting moderately heavy items.

• While performing the duties of this job, the incumbent is regularly required to be independently mobile.
• Periods of prolonged sitting or standing at a computer screen.
• This position requires up to 10% travel.

Neptune Medical is located in Burlingame, CA, near the Millbrae Caltrain and BART station.

Pay Range: $28.00 to $32.00 per hour. The actual base pay is dependent upon many factors, such as: training, transferable skills, work experience, business needs, and location. The base pay range is subject to change and may be modified in the future.

Neptune Medical provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.