Associate Quality Engineer

ESSENTIAL DUTIES
• Utilizes the pFMEA to provide inputs in cases of quality incidents or non-conformity.
• Works with quality management, process engineering, manufacturing and other functional groups on regulatory and quality system compliance.
• Works cooperatively and effectively within a team environment to achieve common goals and results, often influencing the outcome of the team(s).
• Receives assigned total project leadership responsibilities on a portion of major significant projects and will be given total management responsibility for smaller projects.
• Interacts with peers across projects to secure resources and commitments.
• Exercises risk management tasks to support in-process quality control and quality assurance, technical specification requirements and provides feedback on various technical processes and procedures.
• With sufficient guidance, performs evaluation, process review, risk assessment, investigation of non-conformity, and solutions to the identified root cause
• Implements and understands FDA or regulatory requirements as necessary.
• Highlights risks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.
• Provides support in problem-solving in applicable processes
OTHER DUTIES AND RESPONSIBILITIES
• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.
• Other duties as assigned by Quality Engineering leadership
• Work direction responsibility may include technicians and junior engineers.

MINIMUM QUALIFICATION REQUIREMENTS
Education
• Bachelor of Science Degree in Engineering, preferred.
• Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
Experience
• One year of GMP manufacturing experience required. Medical Device manufacturing experience preferred.
• Minimum 3 years experience in Med device or related field
Skills
• Demonstrates ability to communicate effectively both verbally and in writing in English and Vietnamese
• Good knowledge and use of relevant PC software applications and skills to use them effectively.
• Strong technical problem solving, analytical & critical thinking skills.
• Requires demonstrated skills in technical innovation, mechanical engineering, injection molding, and plastic parts.
• Understanding of and adherence to current ISO 13485, GMP practices and FDA regulations.
• Strong interactive skills in general communication, cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team member, team behavior, and support to quality engineers and management.

Premium Healthcare

Laptop

Cellphone provided

Cập nhật gần nhất lúc: 2022-10-01 18:12:04