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  Ensure the Company is compliant with all appropriate regulatory requirements worldwide.
• Provide regulatory support as part of FDA submission team.
• Ensure the quality system requirements are effectively established and effectively maintained in accordance with Section 820.20 of the Quality Systems Regulation, ISO 13485: 2003, MHLW and other regulations worldwide, as applicable. Develop and implement Quality System procedures.
• Apply and exercise audit readiness skills and techniques within the organization and participate in External and Internal Quality audits as a member of MMA Quality Audit Team.
• Review and approve Quality System documentation; approve and close all NCRs, TSRs, CAPA, and Internal Audit related Corrective Actions, when leading Internal Audits.
• Review and approve all validations as appropriate.
• Manage the functions of QA Lab.
• Manage NCR-CAPA Program.
• Monitor and track corrective actions for nonconformance reports, process variances, internal and supplier audits, etc., to ensure both short and long-term corrective actions have been implemented and are effective.
• Manage the Disposition of raw materials, in-process, and final products.
• Perform Regulatory Review of Batch Record for content as needed.
• Analyze manufacturing and quality data and make recommendations for improvement.
• Perform additional responsibilities as needed, requested or required.

• 
  Ensure the quality system requirements are effectively established and effectively maintained in accordance with Section 820.20 of the Quality Systems Regulation, ISO 13485: MHLW and other regulations worldwide, as applicable.
• Review all DCO’s for Regulatory compliance, approve and close all NCRs, CAPAs and Internal Audit related Corrective Actions.
• Review and approve all validations as appropriate.
• Track and Trend Process Variances.
• Manage implementation, support and maintenance of company-wide Quality Objectives, including analysis and trending of key quality system elements.

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  High Level of presentation and communication skills
• Effectively communicate in English (verbal and written)
• Proficient in Microsoft Office (Excel, Word, PowerPoint, Outlook).
• Working Knowledge of quality engineering principles and statistical methods.
• Strong technical background in Chemistry and/or Biochemistry
• Working knowledge of QSR and ISO 13485 requirements
• Ability to train others in QSR and ISO 13485, TQM, and quality assurance principles.
• Ability to conduct Internal and External (Supplier) quality system audits.
• Ability to use TQM tools and statistical methods to solve problems and improve processes.
• Working experience with NCR and CAPA systems.
• Experience with Regulatory Affairs including Federal and State Establishment Registrations, US FDA Regulatory Requirements, and International Product Registrations.
• Ability to work well with cross-functional teams.
• Detail oriented

• Bachelor of Science or Engineering with a minimum of 5 years’ experience working in a Quality and Regulatory field in the Medical Device/FDA/ISO regulated industry required.
• ASQ Certified Auditor/Engineer preferred.
• Previous Supervisory experience is desirable.

• Professional Office Environment
• Laboratory Environment
• Occasional potential exposure to chemical/hazardous materials and bio-hazardous waste
• Occasional Potential Exposure to a cold room (2-8°C) environment for up to 20 minutes at a time
• Must wear protective equipment such as safety glasses, lab coats, hairnets, hard hats, face shields and any relevant equipment deemed as necessary.

• Long periods of sitting (continuously for up to 4 hours at a time and up to 8 hours total in a day)
• Frequent use of mouse and keyboard (continuously for up to 4 hours at a time and up to 8 hours total in a day)
• Long periods of viewing computer monitor (continuously for up to 4 hours at a time and up to 8 hours total in a day)

Affirmative action plan/equal employer opportunity (AAP/EEO) statement:

Minaris Medical America, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Minaris Medical America, Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.