Quality Engineer

JOB SUMMARYWork 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 DUTIESWith 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 RESPONSIBILITIESWork 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 REQUIREMENTSEducationBachelor’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.ExperienceMinimum 3 years’ experience in Med device or related fieldOne year of GMP manufacturing experience required. Medical Device manufacturing experience preferred.SkillsRequires 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.