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Quality System Manager   (44253-5)

The Quality Systems Manager oversees all aspects of xxxx America Inc.’s quality management and technical service functions. This position plans, leads and executes quality management initiatives, and designs Standard Operation Procedures, to ensure compliance with the industry’s legal/regulatory requirements. This position is also responsible for Technical Service and Facility and Safety Management functions.

Quality Assurance
1. Ensure that xxxx America Inc. (MAI) products, processes, facilities and systems conform to all applicable external regulations, including Food and Drug Administration (FDA), Quality System Regulations (QSRs) and International Organization of Standardization (ISO) requirements for medical devices.
• Define and document quality control inspection and testing measures and metrics
• Create and implement annual internal audit schedule to monitor processes, facilities and systems to identify any non-compliance or risk-prone areas, notify the top management and relevant departments and work with them to address and correct issues
• Serve as the key contact with external auditors and arrange and support their audit activities
• Educate MAI employees on applicable procedures based on ISO 13845 by updating Standard Operating Procedures and monitoring internal operation procedures on a regular basis to ensure that the ISO requirements are met
• Assist and/or prepare documentation for domestic or international regulatory submissions of new or existing products and, when applicable, work with outside agencies to clear key regulatory issues and expedite approvals
2. Develop, implement and monitor the performance of QA processes, and maintain and update the document control and tracking database
3. Design and conduct quality management training to all new hires and implement self-training courses to assure continued compliance: when applicable, provide re-training

Technical Services

1. Manage the Technical Service Department:
• Understand the technical requirements of the customers for the products that we distribute, and assign technical support personnel to ensure that the customers’ technical needs are met on a timely manner
• Plan Technical support staffing so that there are no delays or discrepancies in technical support

New Product Development

1. Serve as a key member in project teams to develop new products, and share insight from a technical perspective

Facility and Security

1. Work with Human Resources and hold overall responsibility over MAI’s facility maintenance and layout, including negotiations with the landlord and contractors
2. Work with Human Resources to review applicable OSHA procedures and documentation for successful implementation of the facility. Participate in Sate Government and Worker’s Compensation audit

The physical demands described here are representative of those that must be met by an employee to successfully perform essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Duties are performed while sitting at a desk for a long period of time, utlizing standard office equipment such as computer, photocopier or telephone. Walking or standing within the office, warehouse and shipping/receiving areas is required. Bending, climbing, stooping, kneeling and pushing regularly may be required.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Within the Office, Inspection Lab and/or Repair Room, the employee may be exposed to sharp objects, small tools, various testing and other medical equipment. The noise level in the work environment is usually low to moderate.

MINIMUM QUALIFICATIONS – The qualifications below are the knowledge, skills, and abilities required to do this job. Must be computer literate and be able to clearly communicate verbally and in writing. Proficient in Microsoft Office. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
1. Bachelor of Science degree in engineering, or any relevant technical studies
2. Ten years of progressive responsibility of ISO 13485 and 21 CFR Part 820 Quality Systems implementation in the Medical Device industry, including Regulatory Affairs and Quality Management experience in a medical device manufacturing or medical device distribution environment
3. Strong interpersonal and communication skills, including written and verbal skills, with presentation and negotiation experience
4. Working knowledge of QA auditing with attention to detail and ability to identify issues
5. Ability to manage and enforce company polity to all employees
Ability to manage, develop and motivate department members

詳細情報Job Detail

Job Category Manufacturing
Position Quality System Manager
Job Order # 44253-5
Salary $ 100K + Bonus (18 % )
Working Location Union City
Hours 9 - 18
Days M - F
Bonus Yes
Parking Yes
Medical Yes
Dental Yes
Holiday Yes
Sick Leave Yes
Vision Yes
401K Yes
Profit Sharing Yes
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