The Associate Quality Engineer role is typically an entry level position that takes direction from an upper level Quality Engineer/Manager. The scope of the position is to develop root cause and corrective action skills by working hands-on in a value stream environment. As the AQE develops RC/CA and technical ability within the value stream, he/she will provide hands-on QE support for Engineering and Production under the direction/support of an upper level Quality Engineer/Manager. The AQE will provide audit support for third party audits and customer audits, participates on the internal audit team, and interacts with customers and suppliers.
Essential duties and responsibilities
Provide Quality Engineering support for the assigned value stream. Review document and procedure changes for quality requirements and compliance with the Quality System. Develop Quality System and procedures as needed. Participate as a member of the MRB for the disposition of material. Contribute to the development and implementation of IQ, OQ and PQ protocols to ensure compliance with the Quality System. Support the implementation of continuous improvement initiatives for production processes. Comply with all work rules including those pertaining to safety, health, and quality. Perform other duties as necessary.
Environmental working conditions
Normal office environment
Demonstrated desire to expand his/her knowledge of Quality Systems and support operational growth. Must be familiar with and understand recognized regulations and standards such as:
- US - 21 CFR Part 820 (FDA QSR, cGMP)
- ISO 13485 - (EN) ISO 13485 Medical Devices - Quality Management Systems
- ISO 14971 Risk Management
Able to be technically comprehensive and knowledgeable including standard business ERP systems, as well as technical aspects such as statistics, documentation, SPC, Geometric Tolerancing and mechanical drawings and associated software packages. Familiar with Six Sigma and/or a history of lean manufacturing, Kaizen and 5S, etc. Six-Sigma certified or willing to obtain certification preferred. Must possess excellent verbal and written communication skills, as well as presentation and organizational skills. Ability to interface with customers, problem solve and drive solutions to meet customer requirements. Strong communicator with internal and external customers in all areas of the business. Rational thinker: good business judgment and ethics. Entrepreneurial attitude and mindset combined with the appropriate process orientation, focus and willing to embrace change. Self-motivated with a sense of urgency and accountability. Energetic and hardworking. High level of intellectual curiosity combined with strong problem solving and analytical skills. Innovative, practical, technically astute, and capable of healthy dialogue in the exchange of ideas in reaching conclusions.