We are looking for a Quality Engineer to join our client in Cambridge, Ma on a direct hire basis.
The Quality Engineer will provide support for product Quality through the application of capability analysis, SPC, DOE, and other statistical techniques. Responsible for day to day Quality operations supporting primary drug container development and manufacturing.
Essential Job Function
- Support the development and documentation of the device design throughout development and manufacturing
- Work with contract manufacturing organization to develop, validate, and monitor the primary drug container manufacturing process
- Understand and implement GMP fill/finish requirements
- Review master batch records and perform batch release
- Design, analyze, and provide support on product quality and capability studies to assist company in meeting goals.
- Conduct first piece studies and report on same.
- Must be able to interact with customers as well as internal in a professional manner both orally and in written communications.
- Maintain control over inspection process, policies, SOP, GMP and ISO-13485, 9001 and 15378 requirements
- Establish and maintain key performance indicators.
- Assist in maintaining the ISO 13485:2016 Quality Management System.
- Conduct internal and supplier audits
- Supports regulatory filings, external audits, due diligence, and personnel selection
- Identify specific training needs and periodically review training effectiveness of subordinates.
- Responsible for housekeeping and safety awareness.
- Performs other non-essential duties as needed or assigned.
Experience, Education & Training
- BS degree in a technical discipline with an emphasis on statistical concepts, and 3 years’ experience OR AS degree in a technical discipline and 5 years’ experience.
- Experience with primary drug containers is essential. Ability to learn manufacturing processes, SOP, GMP and ISO-13485, 14971, and drug container standards (e.g. ISO 11040 series).
- Knowledge of SPC, inspection, measuring and test equipment, blueprints and personal computers. Good problem solving abilities.