The primary responsibilities for the Senior Quality Engineer position will be to provide leadership to the organization in the areas of Supplier Quality, Quality Systems improvements and general Quality support that improves overall product Quality.
- Ability to work effectively with colleagues in cross-functional or departmental team projects.
- Incorporate systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues within products and processes.
- Maintain quality control systems around CAPA and non-conformances.
- Support the development, qualification, and on-going manufacturing of purchased and manufactured products to meet requirements.
- Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
- Assist Regulatory Affairs and Engineering personnel in new product/process design to assure effective control procedures are established.
- Perform risk assessment activities to identify product quality or compliance risks and lead efforts to mitigate those risks through Component Qualification and Process Validation.
- Lead Quality Improvement projects as required to support business deliverables.
- Assist quality management in all audits (FDA, Notified Body, Supplier)
- Experience with medical device, or equivalent regulated industry, for a minimum of 4 years
- Working knowledge of Quality System Regulation (QSR; 21 CFR 820), and ISO 13485.
- Experienced auditing to ISO 13485 and the QSR (21 CFR 820) Quality standards.
- Demonstrated ability to work independently and effectively manage multiple priorities.
- Strong organizational, written, and verbal communication skills.
- Bachelor's degree in Science or Engineering.
- Trained Lead Auditor, preferably to ISO 13485:2016.
Physical Requirements and Working Conditions:
- Typical office environment with flexibility for travel to Suppliers as required to support the business.
- Must be able to use basic office equipment: computer, printer, copier, telephone, etc.
- Must be able to remain stationary for long periods of time.
- Must be capable of communicating with stakeholders through various means.