Sr. Quality Engineer

The Sr. Quality Engineer will ensure compliance to required standards including FDA and ISO during process development and the manufacturing of medical device components. In addition, this person will have responsibility for identifying and driving improvements related to quality, compliance to regulatory requirements and business efficiencies within the Quality Organization.

Essential Duties and Responsibilities:

• Represents and provides quality support for new product development initiatives.
• Provides documentation and support for the submission of FDA 510Ks.
• Leads risk management activities for product and process design projects including PFMEA risk assessments.
• Verifies and validates design and processes utilizing IQ, OQ, and PQ process.
• Develops and writes test methods.
• Creates documentation for manufacturing, quality control, and final release processes.
• Generates formal test protocols and reports.
• Conduct data analysis using Minitab or equivalent statistical software.
• Supports continuous process improvements through detailed data analysis
• Support the Corrective and Preventive Actions Program by completing investigations and implementing actions as applicable
• Reviews and approves complaint investigations
• Train manufacturing/QC personnel as needed on test methods or manufacturing processes.
• Document test results per GDP, ISO and FDA requirements.
• Lead process improvement projects to reduce costs.
• Assists with environmental monitoring of production facilities and equipment.
• Develops and implements company policies and procedures.

Qualifications:

• Minimum of Bachelor's degree in technical field (i.e. Bioengineering, Electrical Engineering, Mechanical Engineering or other technical field) and minimum of eight (8) years experience.
• Ability to work in a fast paced, collaborative team environment
• Ability to handle multiple projects and coordinate cross functional teams
• Ability to communicate effectively with management, peers and external vendors
• Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
• Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies in a medical device environment.
• Demonstrated understanding of risk management and risk analysis methods
• Ability to write technical documents (procedures, test methods, protocols and reports)
• Ability to conduct data analysis using Minitab
• Ability to recommend technical solutions
• Ability to specify requirements for products and equipment
• Ability to train other engineers/manufacturing/QC/technicians
• Ability to work with little supervision
• Ability to use personal computers including software such as: Word, PowerPoint, Excel, Project and Minitab
• Self-starter and highly motivated
• Sterilization and microbial experience is a plus