Quality Engineer

JOB SUMMARY
Work requires analytical thinking and logics in the independent evaluation, investigation, and solution for NC/Complaint. Performs work which requires a knowledge of precedents in the specialty area and a good knowledge of principles and practices of related specialties. Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, and company practices and policies.
ESSENTIAL DUTIES
· Implements and understands FDA or regulatory requirements as necessary.
· Utilizes the pFMEA to provide inputs in cases of quality incidents or non- conformity.
· With minimum guidance, performs evaluation, process review, risk assessment, investigation of non- conformity, and solutions to the identified root cause.
· Highlights risks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.
· Exercises risk management tasks to support in- process quality control and quality assurance.
· 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).
OTHER DUTIES AND RESPONSIBILITIES
· May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.
· Work assignments may require additional development and a maturing of in- depth engineering skill(s) or breadth.

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
· Requires demonstrated skills in technical innovation, mechanical engineering, fluids engineering, and cellular biology.
· 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.

Laptop, Chế độ bảo hiểm, Du Lịch, Phụ cấp, Xe đưa đón, Đồng phục, Chế độ thưởng, Chăm sóc sức khỏe, Đào tạo, Tăng lương, Nghỉ phép năm

Cập nhật gần nhất lúc: 2025-11-01 02:35:02