Senior Quality Engineer (Complaints)

Terumo Aortic; United Kingdom; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading company in the medical device sector invites applications for the role of Senior Quality Engineer (complaints). This position involves ensuring compliance in complaint processes, training team members, and providing quality engineering support to enhance customer satisfaction and regulatory adherence.

Qualifications

• Clinical background in healthcare is highly desirable.
• Six Sigma qualification preferred.
• Proven experience in a regulated industry essential.

Responsibilities

• Maintain and oversee complaints processes ensuring compliance.
• Provide guidance on complaints investigation and risk assessments.
• Support the development of team members for effective processes.

Skills

Quality Management Systems

Root Cause Analysis

Lean Methodology

Data Analysis

Complaints Documentation

Education

Relevant Science/Engineering Degree

Job description

Terumo Aortic are currently looking to recruit a Senior Quality Engineer (complaints) to join our team. This role will provide Quality Engineering support to the complaints team including investigation and root cause analysis; review and analysis of returned complaint samples; complaint trend analysis and complaint reportability decisions. This is a fantastic opportunity to join a business where you can truly make a difference and enjoy career development.

The main responsibilities of the role are;

• Maintain all aspects of the complaints processes, ensuring compliant procedures and methods are in place for all related activities.
• Provide consultation and guidance on complaints investigation, impact assessments, risk assessments, and ensure implementation of good complaints practices.
• Provide support and resource to other functional areas to assist with complaints investigations and resolutions.
• Create, review, and Approve complaints and decision reports within stipulated time frames.
• Work collaboratively with other functional areas to effectively investigate and resolve complaint sourced product and process quality issues, deploying appropriate tools to assist complaints decision and risk assessment.
• Generate and maintain trending data for the complaints processes and publish as part of QMS KPI dashboard.
• Provide trending data and reports upon request to senior management, functional managers, regulatory authorities and customers.
• Support the complaints Review Board, performing data analysis, creating updated presentation materials, hosting the meeting and creating meeting minutes.
• Support the development of complaints team members to deliver effective and compliant process, including the timely closure of quality events, NCRs, CAPAs and associated actions owned by Complaints Team.
• Provide input to dFMEAs and pFMEAs as appropriate
• Develop and deliver training materials for complaints team
• Development of effective internal and external customer relationships to ensure quality and regulatory compliance for the business.
• Support internal and external audits as SME for complaints.
• Own any complaints or vigilance related Gap Analysis and ensure that procedures are reviewed and updated to meet the regulatory requirements.
• Identifying opportunities to improve processes through use of Lean Methodology or operational excellence principle and tools.

The successful candidate will possess;

• Relevant Science/Engineering Degree or equivalent.
• Clinical background e.g. radiographer or cardiovascular clinical knowledge is highly desirable
• Six Sigma qualification preferred.
• Proven experience in Quality Management Systems in a similar role within a medical device environment.
• Solid experience in a global company within a regulated industry, preferably medical device or pharmaceutical manufacturing
• Experience of Medical Device Directive and related regulations, such as ISO13485, 21 CFR Part 820, MDSAP, MDD (93/42/EEC) and MDR (EU 2017/745).
• Knowledge and understanding of applicable regulations, especially in relation to MDR/MIR reporting.
• Proven ability to manage and prioritise work load, meet deadlines and work in a pressurised environment.
• Must be able to work cross-functionally and be able to lead teams Complaints quality Engineers and Investigators to complete appropriate complaints documentation for products and processes.