Quality Compliance Specialist
We are seeking a Quality Compliance Specialist to support our manufacturing facility and quality department by ensuring compliance to our FDA regulated and ISO certified Quality System.
Job Duties:
Perform quality assurance functions related to deviations, OOS investigations, nonconforming material processes and overall product quality.
Specialize in overall compliance to companywide specifications surrounding our medical device manufacturing environment, incoming material, process control, inventory control, and internal/external customer service
Ensure activities and items are in compliance with both company quality assurance standards and applicable government regulations, such as GMPs and ISO requirements
Develop, modify, apply, and maintain quality standards and evaluation methods for products and processes
Apply effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality and compliance issues
Establish and maintain good customer rapport, while driving solutions to meet business needs. Develop and maintain a strong spirit of partnership
May assist in the development of contracts and procedures to ensure compliance
Skills Required:
Knowledge and experience with applicable FDA regulatory requirements and Quality Management Systems for regulated medical device is required
Must be accurate, attentive to details, creative, innovative, and must understand and adhere to Standard Operating Procedures, QSRs (Quality System Regulations), FDA 21 CFR part 820 and other government regulations and have a thorough understanding of cGMPs for medical devices
ISO 13485:2003 knowledge and experience is required
Demonstrated knowledge of deviation methods and report preparation
Also required is demonstrated evidence of a solid background of non-conforming product experience combined with the proven ability to successfully direct investigations and influence people at all organizational levels
LEAN problem solving and standard work exposure preferred
Experience/Schooling or Degree Required:
A minimum of 3 years' experience in Manufacturing, a Quality function, within medical device environment
Experience should include close working relationships with Manufacturing, Marketing and Engineering functions
Experience interacting with internal/external auditors is a plus
Experience with electronic document control systems is desirable.Estimated Salary: $20 to $28 per hour based on qualifications.
Job Duties:
Perform quality assurance functions related to deviations, OOS investigations, nonconforming material processes and overall product quality.
Specialize in overall compliance to companywide specifications surrounding our medical device manufacturing environment, incoming material, process control, inventory control, and internal/external customer service
Ensure activities and items are in compliance with both company quality assurance standards and applicable government regulations, such as GMPs and ISO requirements
Develop, modify, apply, and maintain quality standards and evaluation methods for products and processes
Apply effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality and compliance issues
Establish and maintain good customer rapport, while driving solutions to meet business needs. Develop and maintain a strong spirit of partnership
May assist in the development of contracts and procedures to ensure compliance
Skills Required:
Knowledge and experience with applicable FDA regulatory requirements and Quality Management Systems for regulated medical device is required
Must be accurate, attentive to details, creative, innovative, and must understand and adhere to Standard Operating Procedures, QSRs (Quality System Regulations), FDA 21 CFR part 820 and other government regulations and have a thorough understanding of cGMPs for medical devices
ISO 13485:2003 knowledge and experience is required
Demonstrated knowledge of deviation methods and report preparation
Also required is demonstrated evidence of a solid background of non-conforming product experience combined with the proven ability to successfully direct investigations and influence people at all organizational levels
LEAN problem solving and standard work exposure preferred
Experience/Schooling or Degree Required:
A minimum of 3 years' experience in Manufacturing, a Quality function, within medical device environment
Experience should include close working relationships with Manufacturing, Marketing and Engineering functions
Experience interacting with internal/external auditors is a plus
Experience with electronic document control systems is desirable.Estimated Salary: $20 to $28 per hour based on qualifications.
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