SIMPIRICA SPINE, INC.  -  Quality Engineer

Simpirica Spine is a venture-backed Bay Area medical device company located in San Carlos, California.  We are seeking a quality engineer to support the development and maintenance of company’s quality systems.  The individual who fills this position will become a key member of a small, dynamic organization focused on innovative medical device development.

Application Process:  Please send resume to 2010jobs@simpirica.com.  No phone calls please.

Major Duties and Responsibilities:

• Write and release protocols to support shipping validation, shelf life validation and other product/process validations. 
• Perform Incoming Quality inspection of product.
• Develop quality assurance specifications, test methods, inspection requirements, sampling plans and related written procedures. 
• Conduct quality audits (internal and supplier) and develop subsequent corrective and preventive action programs. 
• Coordinate the reporting, analysis, and resolution of material non-conformance incidences.
• Participate in Material Review Board meetings. 
• As needed, perform or participate in Customer Service activities such as order processing, complaint investigation, and/or shipping. 
• Provide support in the rapid resolution of product complaints and/or safety issues. 
• Coordinate the identification, assignment, monitoring, and completion of product improvement or cost reduction projects. 
• Qualify and implement Document Change Requests involving product or process changes.
• Provide quality assurance appraisal and approval or disapproval of suppliers. 
• Assist Quality Department in interfacing with the Notified Body, FDA or other regulatory agencies in case of on-site audits. 
• Complete projects in a manner consistent with corporate objectives. 
• Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products.  
• Coordinate calibration of all equipment.
• Coordinate activities of technicians and temporary workers as needed. 
• Perform duties in compliance with the Simpirica Quality System.
• Support and ensure compliance with FDA, ISO, and all applicable company quality standards.

Education/Experience Requirements:
BS in Mechanical Engineering, Chemical Engineering or Material Science/Engineering.

Experience Requirements: 
2-6 years of work experience in the medical device industry.

Other Qualifications:
Knowledge of regulations such as GLP, GMP, ISO 13485 and other international regulatory requirements.  Working knowledge of statistical methods is required.  ASQ certification is preferred.

Notice to Recruiters / Staffing Agencies:
Please do not submit resumes through this web site. Resumes submitted through this web site will be considered unsolicited. In addition, Simpirica, Inc. will not be obligated to pay a referral fee for resumes submitted through this site and only pays referral fees to those agencies and recruiters with whom Simpirica has a signed contract. Any attempt by recruiters and search firms to directly contact employees or managers of Simpirica is deemed inappropriate and may hinder the opportunity for a future professional relationship with Simpirica.

CONTACT:  2010jobs@simpirica.com