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Manager/Sr. Manager, Quality Assurance

R&D Partners

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Location: San Carlos, CA Posted Date: 4/27/2013 Position Type: Full time Job Code: RDP MDQ5693 Required Education: Bachelors Degree Areas of Expertise Desired: Quality Assurance

Description

Manager/Sr. Manager, Quality Systems

An innovative medical device company is seeking an experienced Quality Manager to oversee the ongoing development and implementation of medical device Quality System.  

MAJOR DUTIES AND RESPONSIBILITIES:  

•   Create, implement, maintain and verify Quality Management System.

•   Manage and direct quality planning activities.

•   Generate and review applicable quality system documentation including SOPs, Work Instructions, test protocols and reports, risk management documents, design development documents, labeling and other quality system documentation

•   Support design control activities including development and maintenance of appropriate documentation such as risk management reports and design history files and other documentation related to change control.

•   Manage documentation and promote good document practices in compliance with 21 part 820, ISO:13485, EU Medical Device Directive(s), and any other pertinent country specific medical device regulatory requirements.

•   Perform and/or coordinate internal audits and assessments of the Quality System with suggested changes for continuous improvement.

•   Prepare monthly metrics on corporate compliance to the established Quality System.

•   Coordinate, implement and maintain procedures and processes related to external vendors in conjunction with other departments.  Procedures and processes can include but are not limited to audits of external vendors for acceptability, preparation of audit reports and maintenance of ongoing surveillance documentation.

•   Manage review of device history records, analytical data and deviations associated with production of product.

•   Develop inspection documentation and support incoming inspection of materials.

•   Coordinate and/or assist in preparation of regulatory approval applications and Technical Files.

•   Prepare for, coordinate and assist with Regulatory Audits.  

•   Comply with and help to enforce and improve standard policies and procedures.

•   Provide guidance to project teams/subordinates/etc. and other disciplines to ensure compliance with company policies and procedures as well as FDA, EU medical device regulations and other pertinent country specific medical device regulatory requirements.

•   Perform duties in compliance with the Quality System.

•   Support and ensure compliance with company quality standards , FDA, applicable EU Medical Device Directive(s), applicable ISO standards,  and other pertinent country specific medical device regulatory requirements.

•   Other duties as required.

Requirements

•   BS degree (engineering degree a plus).
•   Broad-based Quality experience with medical devices and a minimum of seven years related experience in the medical device industry.  
•   Three to five years of experience as a Quality Manager including direct management of Quality personnel.
•   Working knowledge of FDA QSR, ISO 13485, and MDD regulations.  
•   Excellent attention to detail and documentation practices and efficient multi-tasking abilities.
•   Energetic self-starter with strong initiative and sense of ownership.  

LOCAL BAY AREA APPLICANTS ONLY

EMAIL RESUME TO: mstringer@r-dpartners.com
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