Quality Engineer in Manchester

Job DescriptionJob Description

Quality Engineer

• Local Candidates Only - No Relocation
• Mid-Level / NOT Sr. Level

Position Overview:
This position will support manufacturing quality operations in a dynamic, fast-paced, medical device manufacturing environment. This environment includes the manufacture, inspection, and test of devices for design verification, design validation, and commercial production.

Responsibilities:

• Work cooperatively with other team members and in compliance with applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016 to transition products from development to manufacturing.
• Use experience within medical devices, to provide guidance and assistance in the development of new production processes
• Drive the development, implementation, and approval of PFMEAs and control plans.
• Facilitate the development, implementation, and approval of Device Master Records and Device History Records.
• Review existing procedures and for continuous improvement and improved workflow
• Lead investigations resulting in root cause and corrective actions through use of data analysis, inductive and deductive reasoning, and problem solving skills.
• Collect and evaluate data, lead system and process improvements using six sigma tools
• Participate in ISO 13485 audits and assist in FDA and other regulatory inspections

Qualifications and Skills:

• 3 + years of experience in occupation related to Quality Control of medical devices.
• Experience with compliance, with applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016 is required.
• Experience participating in internal and external audits.

Education: 

• Bachelor’s degree or equivalent experience in Industrial, Mechanical or related engineering / life sciences related discipline.