As a Quality Engineer you will collaborate with the Quality Assurance team to ensure process development, manufacturing, and delivery of the highest quality and safe products to our customers and patients.
Responsibilities include:
Proactively identify, communicate, investigate, and resolve quality issues.
Identify and control nonconforming materials, lead investigations to determine root causes, plan and execute product disposition decisions.
Support and/or lead CAPA activities, including root cause analysis, implementation, effectiveness checks and closure.
Participate in risk management activities, including risk analysis and mitigation.
Train and guide manufacturing teams on quality policies and procedures.
Collaborate with cross functional teams to support new process development and process validation activities.
Requirements: Bachelor's degree in engineering, life-science, or related technical field.
Minimum of 3 years experience in quality or engineering roles in Medical Devices (preferred) or related industry.
Excellent English with capability to independently author quality and engineering documentation in English.
Strong written and verbal communication skills.
Ability to read and interpret technical drawings, procedures, and protocols.
Working knowledge of medical device regulations and standards.
Preferred Qualifications:
Experience in working with electronic QMS software.
Familiarity with ERP systems (such as SAP ).
Ability to work independently with minimal guidance from senior team members.
This position is open to all candidates.
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