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Miles
Km80.5

Manager, Quality Assurance

Ivy Sports Medicine, LLC

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Location: Redwood City, CA Posted Date: 5/2/2013 Position Type: Full time Job Code: mqa040113 Required Education: Bachelors Degree Areas of Expertise Desired: Clinical Research
Manufacturing/Production
Project Management
Quality Assurance
Quality Control

Description

Position: Manager, Quality Assurance
Ivy Sports Medicine is seeking a qualified QA Manager, to be involved in establishing the quality standards and systems as which have direct impact on the marketing of safe and effective products, customer satisfaction, profitability, and applicable country approval (e.g. USA, EU, and Canada).  Involved in establishing and maintaining the Quality Management System in compliance with the applicable regulatory standards, as defined by the ISM Quality Manual.  This includes but is not limited to ISO 13485, European Medical Device Directives (e.g., 93/42/EEC, 2003/32/EC), Canadian Medical Devices Regulations, and other applicable regulatory requirements of countries where products are distributed.  This position reports to the Director of Quality Assurance.
All IVY employees are required to take responsibility for the continuing success of the IVY Quality Management System.

Responsibilities and Authorities
Track, trend, and review customer complaints and Production lot failures.  
Review Deviation, Non-conformance and Corrective Action reports, disposition, and release in-process and final product and Device History Records (DHR).  
Review QC Product stability results.  Recommend, any changes to Production or QC testing procedures, or to existing product expiration dates.  
Review and approve all: Controlled documents and procedures (Batch Records, DMRs, Specifications, SOP, Technical Files/Design Dossiers), including validation reports, labels and label specifications.  
Supervise or perform the review of QC results, completed Production Batch Records, lot records for raw materials, including the disposition and release.  
Initiate MQRB review, and disposition material and product associated with deviations or non-conforming material reports.  
Initiate action to: Prevent occurrence of any non-conformity relating to the product, Identify potential problems with the product or process, and notify management or appropriate personnel of such issues.  
Approve new vendors.  Supervise and assist with the maintenance of vendor files and the list of approved vendors.  
Assist with label printing and software.  Write company Device Master Records (DMR).  Supervise and assist in the development and performance of current good manufacturing practice (cGMP/QSR), ISO, MDD, & CMDR training throughout the company.  
Assist & Support 3rd party audits and internal audits performed by consultants.  Perform and/or supervise internal audits as needed.  
Schedule and/or perform audits on contract labs & outside suppliers and distributors.  
Interact with customers.  Investigate or assist in the investigation of customer complaints.  Maintain customer complaint log and files.  
Participate in and provide QA input for the Production Design Control Process.  
Maintain training records current for applicable job related procedures.  
Authority to stop Production activities if warranted based on an observation or any other information that indicates the quality of the product is compromised
Write company Device Master Records (DMR).  
Supervise and assist in the development and performance of current good manufacturing practice (cGMP/QSR), ISO, MDD, & CMDR training throughout the company.  

Requirements

Education required; BS or Master's Degree in Biological Sciences, or related field.  

Work Experience:
At least seven years' experience in quality assurance, with 3 years or more management experience in a related Medical Device or Biopharmaceutical environment including ISO 13485.  Knowledgeable and experienced with integrating quality improvement concepts and methods, into R&D, manufacturing, and service-based activities/organizations.

Skills:
Working knowledge of mathematics, statistics, and biological sciences.  Working knowledge of computer software including word processing, Excel) and Internet browsers.  Good working knowledge in QC and Production testing procedures and protocols.  Good working knowledge and competency with 21 CFR part 820 (cGMP - QSR), ISO 13485, MDD, and CMDR policies and procedures (this includes other applicable sections of the 800 series of 21 CFR, and applicable European Directives such as 2003/32/EEC).  Ability to interact with employees at all levels, as well as, technical representatives, customers and regulatory agencies.  Excellent organizational and detail-oriented abilities.  Technical writing abilities, problem-solving skills.  Self-motivated with the ability to work with little or no supervision.  Excellent verbal and written communication skills.  Knowledge, understanding, and training of applicable international medical device regulations and requirements for countries where product is distributed.  
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