Post Market Quality Engineer

Summary:

The main function of a Sr Engineer in this quality role is to focus on implementing and optimizing quality engineering practices related to Complaints Investigation, Post Market Surveillance and Risk Management while ensuring a culture of quality and compliance with global regulatory requirements.

Job Responsibilities:

• Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) based on engineering principles; analyze results, make recommendations and develop reports.
• Execute complaint investigations multifunctional approach and issues addressed in a systematic, methodical manner.
• Lead Post Market Surveillance activities for products approved in EU.
• Oversight of all complaints that require investigation through the different phases.
• Ensure on time completion of complaints.
• Work closely with complaint investigation owners to resolve issues and ensure those that have passed their due dates are addressed.
• Ensure complaint investigations are adequate and comply with applicable procedures.
• Develop, update, and maintain technical content of risk management files
• Other incidental duties assigned by Leadership

Skills:
Proven expertise in usage of MS Office Suite including MS Project; Electronic Quality Management System

• Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
  Basic understanding of statistical techniques
  Team player and detail oriented.
  Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
  Strong problem-solving, organizational, analytical and critical thinking skills
  Substantial understanding of processes and equipment used in assigned work
  Good leadership skills and ability to influence change
  Knowledge of applicable FDA regulations for medical device industry
  Strict attention to detail
  Ability to interact professionally with all organizational levels
  Ability to manage competing priorities in a fast-paced environment
  Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
  Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Education/Experience:
Bachelor's degree in engineering required.
5-7 years experience required.