Quality Assurance Manager  (Job ID:  127 QA) 

Location: Upstate, NY

The Quality Assurance Manager will implement, support, and sustain elements of the quality system through procedure generation, training, auditing, and technical support.  The QA manager will be a key resource for ISO, EN, MDD, and QSR requirements, and will provide support to the new product development teams by generating and approving validation studies, capability studies, and by performing FMEA and Hazard analysis. 

Primary Responsibilities:

• Acts as the company’s ISO Management Representative to ensure the Quality Management System is established, implemented, and maintained.  Reports to Top Management any need for improvement with this system.  Ensures awareness of customer requirements throughout the entire company.
• Attends Management Review Meetings to provide relevant Quality Assurance data.
• Coordinates and maintains the Product Safety approvals for the
  U.S. and other countries.  (i.e., Canada,
  Europe).
• Ensures compliance with applicable government regulations.
• Responsible for the development, implementation and strict adherence to the company’s Quality Assurance Program. Develops and/or reviews policies and procedures for all operations involved with the production of products.  
• Oversees the approval of objectives, policies and programs associated with corporate Quality Assurance activities, and periodically evaluates results.
• Ensures all products are manufactured in accordance with the company’s Quality Assurance Program and meet customer specifications.
• Schedules and performs internal quality audits and supplier audits, and reports findings to the executive staff; assists in developing corrective action plans and oversees entire CAR system.
• Reviews complaint trends, RMAs, NCMRs, system  failure analysis, and corrective actions with appropriate personnel and recommends modifications in products or quality standards where warranted..
• Prepares reports and other documentation required by domestic and international regulatory agencies.
• Coordinates inspection and testing procedures for purchased material, in-process and finished products. 
• Signature authority for Quality System documentation and records.  (i.e. product deviations, DCPs, DCNs, ECNs, etc.)
• Directs the continuing review of the Quality Assurance program and the formulation of new or revised procedures to effect improvement, reduce costs and enhance efficiency on a company-wide basis.

Education Requirements: 

The position requires a Bachelor’s degree in engineering or life sciences

Experience Requirements:

• A minimum of five years experience in the medical device industry (Class II or III)
• Must have EXTENSIVE regulatory experience in Class II and/or III medical devices
• Must have submitted 510k Medical Device products.
• Requires ability to assess current company practices with external standards, guidance, and regulations (ISO, FDA, and CE) / Must have taken role during FDA inspections
• Must have global experience (Europe, Japan, Korea, China,
  Australia…)
• Must have exposure to UL and EMC testing. (Software validation experience is preferred!)
• CQE (ASQC)  (recommended).

You can email resumes to Admin@LegacyMedSearch.com 

For additional information, please visit our website at www.LegacyMedSearch.com