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Quality Engineer
Ref No.: 13-00019
Location: scottsdale, Arizona
Experience Level: 2 Years
Start Date: 10/17/2013
 
Key Job Responsibilities
Perform new product development activities in a regulated industry following design control requirements and internal procedures.  Some of these activities include creating design specifications for new products, risk management activities, process validations, packaging validation, aging studies, and sterilization validation.  Perform process validation studies (IQ, OQ, PQ) for suppliers.  Perform engineering analysis of the product performance post market release using quality inputs such as complaints, returns, and rejects. Assist in conducting complaint investigations.  Participate and provide input to training on department/division procedures, and policies. Prepare and present project updates.  Ability to create, review and coordinate corrective action and preventive action (CAPA) activities. Assist in investigating discrepancies and following up on corrective and preventive actions and monitor post-implementation effectiveness Assist in incoming inspection activities. Assist in MRB activities and lot disposition.  Provide QA support. Perform reviews of device history records (DHRs), written procedures, change control, deviation reports, test records and other documentation for compliance to GMPs; Other duties as assigned.  Provide positive example and actively promotes compliance to all standards. Maintain a professional working relationship with internal and external customers and support staff.
Supervisory Responsibilities
None. 
Communication (suppliers, customers, key internal personnel, regulatory agencies, etc.):
Communication capabilities with internal customers (R&D, Marketing, Manufacturing, and etc.), and suppliers.   
Proficiency Training Requirements:
Ability to make and present decisions. Strong interpersonal skills. Advanced problem solving skills.
Skills and Certifications Required:
Must read, write and understand English. Must be detailed in handling information/data. Knowledge of FDA GMP/GLP, Medical Device Directive, ASTM, AAMI, CEN and ISO. A minimum of a Bachelors degree in a technical field.  Statistical analysis and Design of Experiments (DOE) knowledge. Minimum of 2 years experience in a medical device regulated environment.