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Quality System Technician (Manufacturing & Production)
Salisbury, MA 01952
Recruited by: Carol Martin | Recruiter | Andover Healthcare See all my Jobs

  • Hiring Company:  Milliken Healthcare
  • Industry: Manufacturing & Production
  • Compensation: to be determined
  • Expires: Aug 06, 2020
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Job Description

Seacoast manufacturing company is seeking to hire a first shift Quality System Technician. The individual assists with the daily management and maintenance of a medical device quality system. The position reports to the Quality Assurance/Regulatory Affairs Manager. The associate will perform or assist in the following key responsibilities and key duties as well as other duties as requested:

1. Key Responsibilities
• Assist with the implementation and maintenance of a Quality System based on ISO 13485 and FDA Quality System Regulation (QSR)
• Document Control – Responsible for control of all documentation required for the Quality System
• SPI System Owner
• Training – Ensure associate training is completed according to schedule and assist in development of the training program
• Corrective and Preventive Action (CAPA) – Monitor status of CAPAs to ensure they are completed as quickly and completely as possible

2. Key Duties/Tasks
• Identify quality issues as they arise and communicate to management
• Maintain quality system procedures (SPIs) and ensure all necessary documents are properly controlled
• Assist in development and maintenance of an effective quality system training program for all appropriate business associates
• Maintain an effective Corrective and Preventive Action (CAPA) system
• Assist RA/QA manager with preparation and execution of Management Reviews on a regular basis
• Ensure an effective supplier quality assurance system while ensuring supplier corrective actions are timely and effective
• Implement new inspection, measurement and testing systems for quality monitoring and improvement
• Track and report significant quality deviations
• Conduct Batch Record (Device History Record/DHR) reviews
• Assist with quality inspection and product release programs throughout all stages of production
• Participate in new product development activities to ensure proper quality assurance and control plans can be implemented prior to beginning manufacturing
• Participate in audit activities including internal, external, supplier, and FDA audits
• Write and/or review protocols and reports for various quality system activities
• Perform laboratory or in process quality testing on devices or components to verify their compliance

Qualifications:

Very strong administrative skills, MS Office suite or similar
-Associates degree, Bachelors' preferred
-Manufacturing experience preferred.
2-5 years experience with ISO Qualify Systems or FDA QSR documentation.
-Bi-lingual English Spanish preferred.
-Knowledge of ISO and or FDA Quality systems