The Quality Engineer is responsible for the voice of quality during product development. This role will guide the product development team through compliant product development and participate in documenting, improving, and assuring quality during the stage gate development process. The quality engineer may also be asked to participate in Supplier Management and/or other Quality related projects as projects require.
- Lead and engage in content generation for stage gated quality system documents in close concert with the engineering team.
- Design and execute verification and validation activities that are conducted internally in accordance with medical device quality system regulations.
- Provide oversight for verification and validation activities that are conducted at Impel’s manufacturing partners.
- Support product development activities, including the testing and inspection required for design qualification, verification and validation.
- Develop sampling, testing, and inspection plans for development and/or manufacturing with statistical justification.
- Develop and maintain quality plans for sustaining projects, ensuring compliance with applicable regulations and customer requirements.
- Conduct statistical analysis of device data and coordinate implementation of necessary CAPA activities.
- Assist in quality planning and assurance associated with engineering change orders.
- Quality assurance of process and components including process assessment, process control plans, PFMEAs, inspection plans and statistical plans.
- Participate in internal, supplier and regulatory audits.
- Lead risk analysis and the comprehensive approach to risk management activities.
- Assist in responding to inquiries or complaints from customers, regulatory agencies, or others.
- Implement organized decision making including analysis of test data using relevant data analysis methods to support design decisions.
- Lead and manage verification and validation protocols and test reports, creation through release.
- Provide team leadership with respect to Project Documentation, DHF and compliance with appropriate CFRs and SOPs guiding product development.
- Other tasks as assigned
- Degree in Mechanical or Manufacturing Engineering or comparable Scientific discipline
- 5+ years of experience in Quality Engineering, preferably in the Medical Device industry
- Knowledge and proven application of applicable FDA and/or ISO quality system regulations
- Project management and/or experience operating in a matrix based project team
- Excellent document management skills.
- Knowledge of Statistical Process Control (SPC), Inspection Methods and Sampling Plans and Design of Experiments (DOE) is a plus.
- Ability to adapt and respond to the needs of a growing organization conducting research, development and commercial activities
- Effective communication and interpersonal skills are emphasized
- Self-motivated and self-starter