Quality Assurance Engineer
Competitive with excellent benefits
QA Engineer: Shropshire. Some remote.
Based in Shropshire, my client is one of the leading manufactures of diagnostics products for the Chemical Pharmaceutical and Life Science industries.
The position of QA Engineer is based out of state-of-the art production facilities in Shropshire which manufactures the world#39&s best sample preparation and Bio-consumable products.
As a Quality Assurance Engineer, you will work closely with cross-functional internal and external stakeholders to provide quality and regulatory insights.
- Represent the Voice of the Customer as the Quality Assurance representative.
- Ensure ISO 9001:2015 compliance throughout the Quality Management System (QMS), Product Lifecycle Management (PLM), and Continuous Improvement projects.
- Provide Quality oversight and guidance in cross-functional teams for the Product Life Cycle (PLC) and write Quality plans in alignment with the Design Traceability Matrix (DTM).
- Own Quality performance reporting (DPPM, customer feedback, product safety events, etc.) and lead improvement projects.
- Manage customer quality agreements, questionnaires, and SCARs and create necessary communication. Respond to customer inquiries and lead resolution of customer satisfaction issues.
- Lead internal and external (registrar and customer) audits as well as regular site-assessments. Track audit findings and collaborate with site management to develop corrective action plans and drive to closure with team members.
- Partner with Regulatory Affairs to understand and implement requirements such as RoHS, REACH, EHS, SDS, etc.
- Create and conduct Quality training with proper effectiveness verification and traceability.
- Work with customers and internal legal and sales personnel to construct Quality, Change Notification, and Supply Agreements to ensure company interests are protected whilst meeting customers#39& needs.
- Assess and assist with product and process change and non-conformances to determine the need for customer notification.
- Own the communication process to ensure quality
- Bachelor#39&s or Master#39&s Degree in Life Sciences (Chemistry, Biotechnology, Biochemistry, or related)
- Significant experience in a quality-oriented role (quality engineering/control/assurance) and/or Quality Management Systems
- Good knowledge of ISO 9001 compliance
- Knowledge of Corrective and Preventive Action process (CAPA) is a plus.
- Knowledge of FDA and medical device regulations is a plus.
- Experience in Liquid Chromatography or Diagnostics markets is a plus.
On a personal level, you are team oriented and open. You also have great communications skills to interact with a variety of stakeholders whilst being capable of working independently as well.
You can expect a competitive starting salary, regular opportunities for progression, continuous learning and training, generous holidays and a host of excellent benefits. Moreover, you’ll be working for a company which treats people, equally, fairly and respectful.
Max File Size 15MB