Quality Engineer

The Role

Reporting to the Director QA/RA, the position will be challenging and will require an ability to work autonomously.  The position requires an experienced and proven candidate with a background in Quality and Regulatory control of Medical Devices. The successful candidate will work as part of a team to maintain high quality/performance standards across the company.

Job Responsibilities include but are no limited to the following:

• Develop and maintain documentation in compliance with FDA , ISO, MDD requirements
• Actively participate in the Documentation control process
• Review / Approve / Release final product documentation
• Initiate / Approve Non-Conformance Reports & Lead Root Cause analysis investigations
• Participate / Lead Risk Analysis initiatives e.g. FMEA
• Initiate / Approve Reworks
• Initiate / Support implementation of effective Corrective / Preventive Actions
• Support the Environmental monitoring process
• Support activities associated with Sterilization
• Act as the QA representative for Supplier Quality management activities
• Represent QA as part of the Material Review Board
• Act as the QA representative on Design Services Projects / Changes
• Initiate / Approve Validation protocols and reports (IQ, OQ, PQ)
• Initiate / Approve Engineering Change notices
• Process Customer Complaints and manage customer replies
• Support Notified Body / Regulatory Agency / Customer Audits
• Perform Internal and Supplier Audits
• Collate and trend Key performance indicator data on a monthly basis
• Actively participate in Management Review & Compliance meetings
• Performs other related duties, as assigned

Requirements

• A degree in manufacturing engineering, quality engineering, life science or related field and a minimum of 3 yrs. experience of working as a Quality Engineer within the Medical Device Industry.
• Candidate must be highly motivated with excellent communication skills and proven ability to work as part of a team.
• Experience of using Lean Manufacturing Tools and Techniques an advantage
• Quality Certification and Lead Auditor Certification while not mandatory would be an advantage.

Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.

Pale Blue Dot® Recruitment

“The Resource for the MedTech Workforce”