Quality & Regulatory Affairs Manager - Derbyshire
Quality and Regulatory Affairs Manager and Quality Engineering roles in Derbyshire. Zest Medical are recruiting for a Quality & Regulatory Affairs Manager for a well established manufacturing and Engineering organisation that operate across a number of industry sectors. Working for their Medical device division you will be required to demonstrate a thorough knowledge of ISO13485 and ISO9001 requirements. In addition you will be able to conduct internal and external audits capable of producing reports and data for Management systems reviews. Any knowledge of FDA / NADCAP style sudit procedures would be advantageous.
Your main responsibilities will include:
- Ensure customer requirements, ISO 13485, FDA and all regulatory requirements within the QMS are implemented and maintained
- Product/Process Quality Planning.
- Evaluation of production processes and identification of potential risk factors by applying FMEA principles.
- Generate action plans to reduce risks and solve potential production quality problems. Plan and set continual improvement objectives.
- Help define features of the product and generate control/testing methods, test equipment and frequency of testing using control plans to meet production requirements.
- Evaluate and define the process flow using process flow charts.
- Creation, evaluation and approval of work and test instructions.
- Defining critical and significant characteristics of manufacture and initiate capability studies to evaluate process stability.
- Initiating root cause analysis using '5' Why or 8 'D' Methodology.
- Identify short-term containment action, preventative action and implement sustaining corrective action solutions.
Ideally you will be a graduate with a degree in a Science or Engineering discipline and/or existing experience and knowledge of ISO 9001/ISO13485 Quality Management Systems, FDA approval or Nadcap style audit procedures. In return you will be offered a competitive salary, benefits package and an excellent opportunity for personal development for candidates who wish to expand and progress into senior management.
Zest Medical, part of Zest Business Group specialise in the recruitment of individuals across the medical, scientific and healthcare sectors
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