Description
Quality Systems EngineerA new opportunity has become available for a Quality Systems Engineer in a market leading medical device firm. The role is a six month contract and you will be require to assure compliance of company operations to all applicable laws, regulations and standards, good business practices and company documented procedures.
Quality Systems Engineers Responsibilities:
- This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including but not limited to FDA, Quality Systems Regulations, ISO 13485, ISO 14001, government occupational health and environmental regulations and statutes).
- To assure regulatory and company policy compliance of all engineering activities with regards to manufacturing processes and product quality.
- Generally, has no direct subordinates; provides functional supervision to QS team members as required. (including but not limited to FDA, Quality Systems Regulations, ISO 13485, ISO 14001, government occupational health and environmental regulations and statutes).
- To assure regulatory and company policy compliance of all engineering activities with regards to manufacturing processes and product quality.
Quality systems Requirements:
- Bachelor's degree from an accredited college or university, or equivalent education to a similar standard.
- Ideally, three to five years direct experience in a medical device industry or regulated company or similar environment with Quality Systems Experience inGMPandISOquality system standards. ISO 9001, ISO 13485 assessor very desirable.
- Trained in Quality System Regulation and documentation techniques.
- Desirable to have been trained in Quality Management Systems, ISO 9001, ISO 13485, and 21CFR820.
- Desirable to have, Internal Auditor Lead Assessor training.
- Good understanding of CAPA systems and implementation.
- Preferably to have an understanding of medical device industry and products.
- Knowledge and skill in engineering documentation procedures, development methods and project management.
- Knowledge of Statistical Process Control (SPC) and quality tools including sampling, tables, and CPK; ability to design and perform required tests using appropriate tools.
Should this be of interest please get in touch to discuss the role further.
To find out more about Real please visit www.realstaffing.com