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.