Assistant QA Manager - Mountain View, United States - Minaris Medical America

Description

The Assistant QA Manager is located in Mountain View, CA.

This position is responsible for ensuring compliance with all appropriate regulatory requirements; Providing regulatory support as part of FDA submission team as appropriate; Defending the company at Regulatory and Quality Audits (FDA, ISO, Customer); Maintaining and improving Quality Systems; Managing various functions to include Compliance to Quality Management System (NCR,TSR, CAPA, Process Variance), Regulatory Review of Manufacturing Records, the QA Laboratory, Certificate of Analysis generation and Quality Systems.

Essential Duties and Responsibilities

• 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 of the Quality Systems Regulation, ISO 13485: 2003, MHLW and other regulations worldwide, as applicable. Develop and implement Quality System procedures.
• 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 longterm corrective actions have been implemented and are effective.
• Manage the Disposition of raw materials, inprocess, 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.

Duties of the Management Representative
The primary responsibility of the Assistant QA Manager is to maintain the effectiveness of the Quality System by performing the following:

• Ensure the quality system requirements are effectively established and effectively maintained in accordance with Section 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 companywide Quality Objectives, including analysis and trending of key quality system elements.

Position Requirements (Knowledge, skills and abilities required to perform satisfactorily in the position)

• 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
• Experience with Regulatory Affairs including Federal and State Establishment Registrations, US FDA Regulatory Requirements, and International Product Registrations.
• Ability to work well with crossfunctional teams.
• Detail oriented

Education and Experience

• 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.

Supervisory Responsibility
This position has supervisory responsibility.


Work Environment

• Professional Office Environment
• Laboratory Environment
• Occasional potential exposure to chemical/hazardous materials and biohazardous waste
• Occasional Potential Exposure to a cold room (28°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.

Physical Demands

• 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)

Position type and expected hours of work
Full Time


Wage Range
$75,000 - $110,000


Travel Demands
Minimum travel may be required as appropriate.

**Affirmative action p