Quality (Design Assurance) Engineer (Work From Home)

Recruiter
CREGG Recruitment
Employment Type
Permanent
Salary
Not disclosed
CREGG Recruitment logo

About the role:

As the newest member of the Design Assurance team, you will demonstrate commitment to the Quality Policy (patient safety and product quality) by executing sound quality practices and maintaining an effective quality system. The key to the success of this function is to fulfil the quality assurance responsibilities of our clients new product development and post-market (commercial product) support, including the application of Design Controls in Product Development and Sustaining Changes to ensure that all design changes are compliant with associated Regulations and Methods. 

Salary: Excellent salary with full benefits including healthcare, pension, bonus etc

Hours of work: 39 hour work week with a 1pm Friday finish

 Key Activities of the Role:

  • Familiarity with requirements and procedures that govern medical device Design Control, Risk Management and Post Market Surveillance.
  • Understanding of Design Assurance requirements to ensure new product/technology transfers comply with all internal and regulatory requirements.
  • Provide design quality support in resolving PIRs, complaints investigation, CAPAs, VIPs, and regulatory requirement changes.
  • Interface with R&D, Regulatory Affairs, Clinical Risk, Medical Safety, Complaints Management Centre and Post Market Quality Assurance team environments to provide technical and quality systems input.
  • Evaluate trending and product performance to support site-level Signal Evaluation Reviews and Complaint Review Boards.
  • Assure completeness and quality of documentation (including test data, inventory records, investigations and deviations).
  • Excellent analytical and problem-solving abilities. Analyse and draw conclusions making appropriate decisions concerning risk management activities.
  • Ensure and maintain regulatory compliance with appropriate guidance documents – company SOP/WIs, cGMPs, EU/FDA/Global guidelines.
  • Leverage knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
  • Demonstrate best practices in line with the department and site objectives and continually seek to drive product and process quality improvements.

 

Qualifications and Experience:

 

  • NFQ Level 8 qualification in a STEM discipline.
  • Minimum of 2-3 years experience in a Design Assurance capacity.
  • Experience in post-market (complaints) support, risk management, design and process change, and standards compliance (to regulatory requirements).
  • Good technical capabilities, communication skills, teamwork abilities and initiative.
  • Proven ability to work well both as part of a team and work on your own with minimum supervision.