PURPOSE

The Senior Quality Engineer is responsible for executing the strategy and direction of the Quality Assurance function.  Responsible for implementing and refining the company’s quality systems and policies and procedures, including compliance of Pristine’s electronic Quality Management System (eQMS) to regulatory standards and requirements.  The Senior Quality Engineer will work with Operations and Product Development as the representative for the Quality function.

DUTIES & RESPONSIBILITIES

Quality

• Lead quality assurance for new product development with focus on design control, risk management, and design reviews.
• Lead complaint management, CAPA program, post market surveillance, and related quality improvement efforts.
• Support process enhancement initiatives that deliver an environment of continuous improvement and high-quality manufacturing output.

Documentation

• Lead deployment of eQMS and provide tactical support for change orders, audit actions, SOP updates, and related elements.
• Serve as Documentation Control representative for all eQMS activities.
• Oversee Quality Training Programs to ensure that Pristine and supplier employees are trained on and adhere to the current SOPs, work instructions, safety requirements, and environmental controls.

Qualification

• Support supplier qualification, audit, monitoring, and supplier continuous improvement action plans. Work with outside vendors for audit activities.
• Assure compliance with FDA requirements under CFR Title 21, ISO 13485, ISO 14971, EU MDA and requirements for other juris
• Control and report on all Key Performance Indicators for Pristine’s Quality function.

QUALIFICATIONS

Minimum

• Undergraduate degree (Bachelor of Science or equivalent) in biomedical, electrical, or mechanical engineering
• Seven (7) years’ experience in Quality Engineering
• Quality Engineering experience in all phases of product development including risk assessment, design reviews, change management, and verification and validation
• Experience with deployment and utilization of an electronic Quality Management System (eQMS)
• Experience and deep familiarity with FDA quality systems regulations, 21 CFR Part 820.

Preferred

• Graduate degree (Master of Science or higher) in biomedical, electrical, mechanical engineering, or a related discipline.
• Ten (10) years’ experience in Quality Engineering
• Experience in a fast-paced, start-up medical device environment
• Strong track record of change management and success working cross-functionally
• Successful deployment of eQMS to meet ISO 13485, ISO 14971, EU MDR and regulatory requirements for other jurisdictions.
• Experience with Greenlight Guru eQMS software
• Able to travel domestically and internationally as needed (estimated at 10%)
• Current Regulatory Affairs Certificate: Medical Devices (RAPS), Quality Engineer certification (CQE) or equivalent.

WORKING CONDITIONS

• Ability to set and meet independent objectives without supervision
• Comfortable in a fast-paced, flexible, growing organization
• Fully remote position: Candidates located in New England preferred

This job description is not an exhaustive list of all functions that the employee may be required to perform, and the employee may be required to perform additional functions. Additionally, the company reserves the right to revise the job description at any time.

Pristine Surgical offers a comprehensive benefits package that includes medical, dental, and vision insurance, a company sponsored 410(k) plan, and open PTO.

To apply, please email CV and cover letter to hr@pristinesurgical.com.