Quality Systems Specialist

and those authorized to work in the U.S. can be considered as W2 candidates. Job Title: Quality Systems SpecialistLocation: Norwood, MA, 02062Duration: 6+ Months, potential to go permanentSchedule: Shift 1; M-F (8:00 AM - 5:00 PM)Description:•The Quality Systems Specialist will participate in the management, governance, and execution of Quality Management sub-systems.•Specifically, the person will be required to interact and collaborate with cross functional teams to promote and drive Quality Systems compliance regarding training, internal/external auditing, and Documentation Control.•Additionally, this role will support specific quality improvement projects as required for QT and other business initiatives.•The individual filling this role is expected to apply problem solving and interpersonal skills and be able to influence and drive results.Major Job Responsibilities •Support the POC Document Control processes within the Edgewater location.•Support the Internal and External Audit processes by participating as an internal auditor and participating in external 3rd party audit processes.•Support the development, monitoring and reporting of Quality Systems key performance indicators (KPIs).•Support the Learn4U Training process.•Assist and the development and presentation of the POC new hire onboarding training program.•Assist in the development and presentation of the POC ISO 13485 training program.Required Knowledge/Skills, Education, and Experience:•2 - 5 years of experience in a Quality role within an FDA regulated industry preferably medical device and diagnostics that includes experience with document control, training, and auditing processes.•ASQ certifications such as CQA, Six Sigma, and CQE, CQT or equivalent are highly desirable.Job Family Responsibilities: •Analyze complex production and quality trend data to identify and solve problems.•Designs and develops systems for recording, evaluating, and reporting quality data.•Perform economic implication analyses, prepares reports of findings and carries out complicated implementation and training assignments.•Conducts complex audits and/or surveys to determine acceptability of quality controls.Education: •Typically AS degree in a related discipline or equivalent combination of education and experience.•Prefer disciplines in English, technical writing, or similar.•Prefer candidates that possess internal auditor certification (CQA) from ASQ or equivalent training in IVD / biomedical industry.Knowledge and Experience: •Demonstrates and applies a broad knowledge of field of specialization through successful completion of moderately complex assignments.•Successfully applies complex knowledge of fundamental concepts, practices, and procedures of particular area of specialization.•Demonstrates knowledge of organization''s business practices and issues.Travel: •10%.Key Working Relationships: •Primarily intra-organizational contacts and external contacts.Benefits: