Quality Systems Engineer

Based in Mansfield, MA with 6 offices across the region we are a TOP ranked Medical Device Manufacturer! Our core values are centered around our people and our clients. We believe that putting your employees first is not only the right thing to do, but it also gives us the competitive edge to ensure our clients have an excellent experience! Over the years our reputation for providing our people with the very best has caught the eye of some reputable clients who have chosen to use us as their primary firm!

If you are an experienced Quality Engineer, then please apply!

We are a global medical manufacturer that produces medical devices and components for everything from implants and surgical instrumentation to single-use disposable devices and assemblies. With over a dozen locations worldwide, we offer extensive opportunities for you to grow and advance your career.

We’re committed to creating an exceptional work environment for all our employees. That includes strong work-life balance, supportive teams, and opportunities for advancement. As soon as you start working with us, you’ll have access to:

Health benefits starting from day one
Retirement plan with company match
Sign on bonus
Off-shift premiums
Relocation benefits

Job Summary

Responsible for establishing and monitoring systems designed to comply with customer and regulatory requirements for the planning and production of medical devices. Manages the development of internal systems and procedures to meet all general customer, ISO 13485, and FDA 820/GMP requirements. Acts as a contact for external audits and regulatory affairs. Responsible for the internal audit function and participates in management reviews.

Duties and Responsibilities

• Responsible for continuous improvement, trending, and tracking of the Quality Management System including
• Non-conformances – Conduct Management Review Board (MRB) reviews and authorize material dispositions.
• Complaints System – Trending / tracking, including leading product investigations.
• Perform Quarterly Business Reviews with other Divisions and integrate in franchise level practices and procedures.
• Manage the Internal Audit program, trend and track data.
• Support 3rd part inspections – FDA, Notified Bodies and Corporate
• Participate in Quality Management System Management Reviews
• Apply statistical methods to evaluate test data and processes.
• Conduct quality systems training of personnel in Quality Control and Quality Assurance procedures.
• Supports and maintains the quality system that meets the ISO 13485 and FDA 21 CFR Part 820 QSR/GMP requirements.
• Verify that all production procedures have been followed and the records maintained correctly.
• Prepares for and represents the company with customer and regulatory representatives who conduct external audits of the corporate quality system.
• Conducts internal audits of the corporate quality system and the other divisions.
• Participates in the internal and external CAPA functions by trending and analyzing the data. Leads project teams to continuously improve the processes and systems.
• Participate in six-sigma and lean manufacturing improvement projects.
• Acts as a point of contact (POC) for all customer required process change requests.
• Provides technical guidance for all Quality Functions.
• Provides process validation assistance.

Education
Preferred 4 Year / Bachelors Degree in Mathematics, Statistics, or related field.

Experience
3-6 years Quality Engineering or related experience.