The primary role of Quality Assurance function is to ensure that management systems are established to enable business compliance, multiple regulatory frameworks and to support the design, development and manufacture of products which meet our customer’s quality requirements. Key deliverables include creating and building relationships with medical device regulatory in every country. Ensure timely registration to meet business needs. Also, responsible for all aspects of auditing to ensure regulation compliance, quality best practice, process improvements and development of supplier quality systems. Provides broad business technical support around QA systems and processes to the organization. Leads and implements significant quality projects across the business and also creates and improves quality and business processes. Capability and process development for compliance and Continuous improvement. Global responsibility for QMS alignment across global quality systems. Maintenance and security of documentation system and record keeping.

Let’s talk about Responsibilities

• The primary objective of QA Engineering specialization within Quality Assurance Job Family is to design, implement and maintain quality assurance protocols and methods for processing materials into partially finished or finished products.
• Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution.
• Designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products.
• Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
• May assure compliance to in-house and/or external specifications and standards (i.e.
• GLP, GMP, ISO, Six Sigma).
• Performs work in a specialized area of expertise that requires knowledge of fundamental themes, principles and concepts. Typically requires a university degree or equivalent work experience.
• Responsibilities might include:
  
  (1) Performing routine professional-based activities (early in career)
  
  (2) Contributing to and managing projects (mid-career)
  
  (3) Providing advice/direction in primary areas of expertise (specialist and expert)
  
  (4) Leveraging professional expertise and relationships to contribute to strategy and drive business results (principal)relationships to contribute to strategy and drive business results (principal)
• Builds productive internal/external working relationships.
• Occasionally leads the work of project teams and might formally train junior staff.
   

Let’s talk about Qualifications and Experience

Required:

Preferred:

• Bachelor’s degree.
• Minimum of 2 to 5 years of related experience.
• Developing professional expertise, applies company policies and procedures to resolve a variety of issues.