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Quality Assurance Engineer

2 months ago

Manchester, United Kingdom Merrimack Manufacturing Full time
Merrimack Manufacturing: Quality Engineer Opportunity

We are seeking a highly skilled Quality Engineer to support our design transfer activities and quality operations in a fast-paced medical device-manufacturing environment. This role involves generating and maintaining control plans, risk management files, validation protocols, and other QMS documentation to ensure initial qualification and launch of commercial production activity.

Key Responsibilities:
  • Evaluate new products, manufacturing processes, and ensure compliance with applicable regulatory standards throughout the New Product Introduction process.
  • Provide input to the development, review, and update of User Requirements, critical quality attributes, and other design documentation.
  • Lead project teams through protocol generation, execution, documentation organization, report writing, and meeting schedules for final approval and release for use.
  • Lead investigations resulting in root cause and corrective actions through data analysis, inductive and deductive reasoning, and problem-solving skills.
  • Develop inspection procedures and sampling plans for new production, continuous improvement of process controls, and improved workflow/worker satisfaction.
  • Assist in the development, implementation, and approval of Device Master Records, Device History Records, and Risk Management Files for new products.
  • Provide guidance and assistance on the assessment of new and changes to existing manufacturing equipment, ensuring proper enrollment into QMS systems and that Validation requirements are met.
  • Lead improvement projects to increase efficiency and compliance within Merrimack Manufacturing's Quality Management System.
  • Participate in Material Review Board (MRB) meetings, track, and follow through with nonconformance reports assigned.
  • Support and contribute towards the success of external audits, whether conducted by the FDA, a Notified Body, other regulatory bodies, or external customers.
Requirements:
  • Candidate must have a B.A. or B.S. degree; equivalent experience in relevant technical fields will be considered.
  • At least 3 years of experience in Medical Device Manufacturing or other similarly regulated industries such as Aerospace, Military, etc.
  • Strong knowledge of CFR Part 820 and ISO 13485 required.
  • Lean and Six Sigma certification strongly preferred.
  • Strong knowledge of IQ/OQ/PQ requirements, measurement system analysis, and supporting engineering specifications.
  • Knowledge of New Product Introduction processes and deliverables.
  • Strong knowledge of tolerance stack up calculations and calibration best practices.
  • Strong organization, communication, and time management skills; Project Management experience preferred.
  • Knowledge of industry standards and best practices for Software Validation, Controlled Environments, Biocontamination Controls, and Gamma Irradiation also preferred.