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

· With minimum 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.

· Works with quality management, process engineering, manufacturing and other functional groups on regulatory and quality system compliance.

· 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.

· Utilizes the pFMEA to provide inputs in cases of quality incidents or non-conformity.

· 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

· Work assignments may require additional development and a maturing of in-depth engineering skill(s) or breadth.

· May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.

MINIMUM QUALIFICATION REQUIREMENTS

Education

·       Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

·       Bachelor of Science Degree in Engineering, preferred.

Experience

·       Minimum 3 years’ experience in Med device or related field

·       One year of GMP manufacturing experience required. Medical Device manufacturing experience preferred.

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.