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Senior Quality Assurance Engineer

Methuen, Massachusetts Globus Medical

Senior Quality Assurance Engineer

Location:Methuen, MA

Job Code:SQAE

Description

The Senior Quality Assurance Engineer will provide leadership in achieving the highest quality level of all parts, products and systems while ensuring compliance with all company policies and procedures and maintaining compliance with US FDA and international medical device regulations and ISO 13485 quality system requirements. Responsible for the management of Quality functions and activities, including the development, implementation, and continual improvement of quality systems and procedures supporting design and development, manufacturing operations, supplier management, field service, documentation and records, training, quality management, and auditing.

Job Responsibilities:
– Perform the quality assurance activities for the advancement of the business through application of advanced quality systems and concepts to include Complaint management, CAPA management, etc.
– Manage the application of the Quality System in determining that components and finished products comply with established specifications and regulations.
– Engage in the new product development process, support process and design quality, and influence decisions regarding design factors that directly affect product quality, safety, service, and cost.
– Participate in the product quality audit programs and QSR/ISO audit programs for the facility.
– Create quality improvement programs.
– Support FDA/ISO inspections. Review issues and participate in decisions related to FDA/ISO.
– Implement and/or facilitate corrective/preventative action for products and systems.
– Track the on-going quality and reliability of all products and provide inputs to the businesses, engineering and/or operations for potential improvements.
– Monitor engineering change activity; review proposed changes for their unintended effects on interchangeability, documentation, testing and functionality and help ensure their successful implementation.
– Participate in the supplier selection process and provide support to purchasing on all quality-related issues through supplier quality assurance.
– Establish and build strong relationships and partnerships across the business to leverage best practices, capabilities, and ideas.
– Establish good customer communication skills especially when dealing with sensitive issues.
– Adhere to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensure Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role.
– Represent the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of Globus.

Qualifications:
– Requires a bachelor’s degree (science or engineering preferred).
– Five+ years of experience in Quality. Experience in the medical device industry preferred.
– GMP and ISO knowledge required.
– Personal computer proficiency with MS Office is required.
– Multi-discipline assurance background is desired.
– Knowledge of quality and/or reliability engineering is a plus.
– ASQ certifications preferred.
– Must be able to make solid decisions that effectively support the business and company policies.
– Travel requirements are as needed.

Globus Medical is an Equal Opportunity Employer. EOE M/F/D/V

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