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Sr. Quality Engineer

  • Location: Hopkinton, Middlesex, Massachusetts
  • Salary: 55-71.4 per hour
  • Job Type:Contract

Posted about 1 month ago

  • Sector: Engineering
  • Start Date: 2021-11-01
  • Job Ref: 21-24075
Blood borne Pathogens Training & Hepatitis B Requirement

Seeking an experienced engineering professional who works well in a cross-functional team environment. The individual will support our efforts to attain and maintain Quality Management System compliance, as well as ensuring that we comply with applicable regulatory and statutory requirements (ISO 13485, ISO 14971 IVDR). Must be able to work independently and resolve Quality Systems and regulatory compliance and quality program related issues in a creative, high quality, timely and cost-effective manner. Core values must include commitment to customer excellence with demonstrated ethics and integrity.

The Quality Engineer - IVDR Compliance role will partner closely with Quality, Regulatory Affairs, Global to support and implement regulatory strategies that optimize development, registration, and lifecycle management of new and marketed products, taking into consideration current and proposed changes in regulatory requirements and standards globally, to facilitate timely regulatory submissions and market authorization/approvals.

Oversee generation, approval, and compliance management of applicable QSR documentation.
Conduct Gap Assessment/Audit/create/review/approve/release production Quality System documents/SOPs/work instructions as required per IVDR
Participate in internal & external audits of applicable QSR/ISO processes to meet regulatory requirements for the site.
Support Americas Quality Team by performing Gap Assessment to comply to IVDR regulations and updating Quality System documentation as needed.
Independently communicate within the project teams as well as Sr. Leadership through project reviews and status reports.
Perform/supervise internal & external audits of applicable QSR/ISO processes and maintenance of applicable QSR databases to meet regulatory information tracking needs.
Review existing DHF files and Perform GAP Assessment and provide guidance to update technical file documentation.
Provide guidance for IVDR Compliance for America Quality Sites
Responsible to work collaboratively with local (US & Canada), International (EMEA, Eurasia, APAC & LatAM) Regulatory teams, and other cross-functional stakeholders to implement regulatory policies, processes & procedures, systems, and reporting mechanisms/tools in compliance with regulatory requirements ensuring alignment with overall business strategic goals/priorities.
Responsible for synchronizing regional in-country regulatory requirements with global/corporate processes, procedures, and systems in collaboration with US, EMEA regulatory and other stakeholders e.g., Quality, R & D, Marketing, Operations, PMS and Doc Control.
Proactively keep abreast of changes in global laws, regulations, standards/guidance and assess their impact and make recommendations to ensure compliance and provide regular reporting across the organization on key developments that impact customers or business directly.
Provide support in general quality program issues to support Quality Department effectiveness.

Requires a BS (MS a plus) in Engineering and/or technical discipline, or equivalent, with minimum of 5-7 years related experience and/or training; or equivalent combination of education and experience
Experience with scientific instrumentation in a design and manufacturing environment; in quality, regulatory, design, or manufacturing role; within a medical device related company; or equivalent
RAPS (RAC) Certification is preferred.
Direct experience with Class II/C (or higher) medical device registrations required.
Working knowledge of International Regulations (e.g., US FDA 21 CFR 820, EU MDR 2017/745 and IMDRF/GHTF.) required.
Quality auditor, regulatory investigator, or equivalent status, and/or also with having performed internal process audits
Working knowledge of Medical Device Regulations and Standards (FDA, ISO 13485, ISO 14971, MDD, IVDD)
Working knowledge of MDR, IVDR. Specifically, Labeling requirements (UDI and MEDDV)
Must utilize lessons learned to improve effectiveness of project teams you will be working with, including aptitude to learn new systems and retain technical information
Energetic, results-driven with excellent organizational and prioritization skills
Excellent written and verbal communication skills and highly effective time management skills
Ability to operate independently and as part of a team
Commitment to continuous improvement principles