This small medical device company is seeking a Senior Embedded Quality Engineer to be responsible for establishing the technical quality policies, procedures and objectives related to Operations and Product Development. Provides support to the Change Management program, Document Control activities, and training for Quality Systems, including, but not limited to oversight of contract manufacturer activities, verification of changes, filing of approved documents, and other duties as assigned.
- Support company goals and objectives, policies and procedures that comply with FDA Quality System Regulations (QSR), ISO 13485, and any other applicable domestic or international quality and regulatory requirements.
- Assure compliance of the technical aspects of the company by successfully integrating these activities with other functional areas within the company, including: Quality, Regulatory/Clinical, Operations, R&D, and Finance.
- Create long-range quality plans for the organization focusing on: Design Control, Risk Management, Statistical Sampling Methods, Supplier Quality, NCMRs, Manufacturing Quality Control.
- Conduct quality audits and coordinates development and implementation of corrective and preventive actions.
- Develop Quality Assurance specifications, test methods, sampling plans, and related written procedures.
- Conduct testing utilizing DOE methodology and other experimental design tools along with generating complex written reports.
- Bachelor’s or Master’s degree in an engineering discipline or equivalent.
- Thorough working knowledge of the medical device industry is required.
- Minimum of 5-10 years of leading embedded quality-related processes within the medical device industry.
- Strong statistical skills.
- Strong written and verbal communication skills to communicate effectively at all levels.
- Good presentation skills to deliver speeches and/or presentations effectively to a variety of audiences.
- Knowledge of product and process software validation strongly preferred.
Visa Requirements: Must be a US Citizen or US Green Card Holder