Quality Engineer

Overview

Large client in medical devices industry. The duties related to the Quality Engineer II role require knowledge and experience in Medical Device industry to support or perform risk assessments, design change quality reviews, and support potential product quality issues in released product portfolio. This encompasses all aspects of a medical device’s lifecycle such as design, manufacturing, distribution and obsolescence. The duties may include technical writing (Design Failure Mode Effect Analysis, and other related technical documentation), creative and critical thinking, and collaborating with diverse teams to resolve quality issues and drive process improvements.

The duties are complex and may involve parallel execution of multiple duties and projects.

The Employee will work on products that support the Core Surgical Innovations (CSI) Stapling product portfolio within the Medical Surgical operating unit. Knowledge of product design helps assess risks and ensure product reliability standards are met.

The Employee’s work will have an immediate impact on the CSI Stapling portfolio and business performance, with significant continuous improvement projects and product/process changes to fulfill market requirements. The role includes performing product quality assessments, reviewing and approving technical documentation related to engineering changes, conducting root cause investigations, reviewing risk management files, and ensuring quality standards for patients and business unit goals are met.

• Develops, modifies, applies and maintains quality standards and protocols for processing materials into partially finished or finished products.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess costs and determine responsibility for products or materials that do not meet required standards.
• Ensures corrective measures meet acceptable reliability standards and that documentation complies with requirements.
• May specialize in areas such as design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
• Specialist career stream: typically an individual contributor with responsibility in a professional discipline or specialty; delivers and/or manages projects and may mentor colleagues.
• Works on projects from design to implementation, adhering to policies and using specialized knowledge and skills normally acquired through advanced education (typically University).

• Top 3 technical skills required for the role:
• technical writing
• data analysis
• project management
• Education Required / Years’ Experience
  
  Required:
  
  Baccalaureate degree with minimum 2 years of relevant experience or Master’s degree with minimum 0 years relevant experience.
• Required Knowledge and
  
  Experience:
  
  Requires practical knowledge and demonstrated competence within the job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.