Quality Systems Engineer IILocation: Boston, MAThe Quality Systems Engineer II is responsible for helping and supporting the Quality Systems organization from the Healthcare Device company location by ensuring compliance of the Global Quality Management System (QMS) with applicable Medical Device standards and regulations.Principle Duties and Responsibilities:Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities.Contribute to the development of Quality System performance measures, data collection, trending, and reporting. Assures that data obtained during all quality activities is complete, accurate and documented consistently with company policies and procedures.Provide support during Corrective and Preventive Action (CAPA) activities and manage the CAPA system as necessary.Support 3rd party audits, NB audits, including follow-up on actions. Part of Back Room crew, communicate and coordinate associated activities across the organization.Support Internal Audit program, e.g., participate/lead Internal audits, follow up on the finding with auditee through effective closure, present the data for trending, etc.Ensure compliance of QMS through authoring and updating Standard Operating Procedures (SOP).Support client global training program.Support New Product Development projects, as needed.Other Duties as assigned.Job Qualifications:BS degree is required.
MS preferred.Lead Auditor Certification is highly preferred.2+ years of Quality Assurance / Quality Systems experience in an FDA-regulated industry (Medical device).Must be proactive and able to work independently with minimal supervision; strong collaboration skills are essential.Knowledge and application of QSR/GMP/GCP/ISO regulations related to medical device manufacturing.Working knowledge and practical application of 21 CFR Part 820, ISO 13485, and ISO 14971.Strong analytical and statistical skillsAbility to Communicate ideas and information clearly, effectively, and frequently (oral and written)Ability to exercise judgment to determine methods, techniques, and evaluation criteria for obtaining results.Able to work in a fast-paced work environment, prioritize tasks and manage multiple projects at once.