Job Title: Senior Quality Engineer

For immediate consideration, please apply directly to this job posting AND email biacosta @actalentservices.com with the following:

1) Word copy of resume

2) 2-3 professional references

3) 4-5 brief bullet points highlighting technical qualifications

Job Description

We're looking for a Senior or Principal Quality Engineer to join our team. This role is crucial in ensuring that our quality system is top-notch and that our products meet all regulatory and company standards. You'll be working closely with various teams to make sure everything runs smoothly and efficiently.

Responsibilities

• Guide and oversee product and process validations, including sterilization validation and revalidation.
• Lead biocompatibility studies to ensure product safety.
• Create and update Risk Management documents as per ISO for new products or design changes.
• Represent Quality Assurance on project teams for new or revised products.
• Investigate product or production issues and develop corrective actions.
• Oversee and help maintain Calibration and Preventive Maintenance Systems.
• Evaluate, develop, and monitor suppliers to ensure they meet our standards.
• Support the maintenance of our quality system in compliance with our Quality Policy and regulatory standards.
• Provide support for regulatory submissions and audits.
• Have signature authority for changes to manufacturing/quality procedures, processes, and designs.
• Provide training and direction for Quality Inspectors and Technicians.

Essential Skills

• Bachelor's degree required
• 7+ years as Quality Engineer within Medical Device, Biotechnology
• Hands-on approach in quality assurance
• Experience in risk management and ISO standards
• Experience in sterilization processes
• Ability to lead and train quality teams
• Knowledge of biocompatibility studies
• Experience in cleanroom environments
• Experience in design control and process validation
• Proficiency in Excel pivot tables
• Knowledge of regulatory compliance and sterile processing

Additional Skills & Qualifications

• Experience in biocompatibility is a plus
• Experience with implantable medical devices

Work Environment

The team consists of 2 Quality Engineers and 3 Technicians, primarily women, working in a company with mostly male employees. The work environment includes cleanroom settings and involves collaboration with various departments to ensure product quality and regulatory compliance.