Senior Quality Engineer

Location: Belfast  |  County Antrim  |  Northern Ireland
Sector: Life Sciences
Consultant: Chris Kerr
Job Reference: CK/HQ280
Salary: £32000 - £35000
Job Status: Permanent / Full Time
Job Title

Snr. Quality Engineer  

Reports To

Manager RA/QA   

 
Position Summary

Responsible for leading a team of quality engineering in integration, supporting activities for MDSAP, ISO 13485: 2016 and MDR in addition to internal audit scheduling, execution and reporting for a class III medical device

Key Areas of Responsibility

The Senior Quality Engineer will be responsible for the following activities:

  1. Overseeing the implementation, adherence and schedule relating to the companys corporate SOP for internal auditing 
  2. Overseeing implementation and compliance SOPs
  3. Supporting updates to labelling, SOPs, work instructions, trending tools and policy documents to comply with MDSAP, ISO 13485: 2016 and MDR
  4. Co-ordination of external audit preparation and execution as required
  5. Co-ordinating MRM, CRB, PRB as required
  6. Managing quality team members on a day to day basis
Qualifications Knowledge Skills
  • Qualifications:

2:1 in Engineering or Science or an equivalent qualification in QA or RA

  • Experience:

Minimum of 5 years’ experience in a regulated medical device or pharma business 

  • Specific Knowledge

An understanding of ISO 13485: 2016

An understanding of MDSAP regulations would be advantageous

Knowledge of 21 CFR part 820

Knowledge of ISO 14971 and ISO 14155 would be advantageous

Previous internal auditing experience and lead auditor training would be advantageous

  • System/Computer Requirements:

Basic Microsoft Office, MS Project, Adobe Acrobat

  • Key Competencies needed for this position?

General knowledge of the relevant regulations

      Organisation of projects and teams

      Effective Communication Skills

      Highly developed technical writing skills

      Highly developed decision-making skills