Quality Systems Engineer

Who is Fikst?

Re:

Build Fikst, LLC (Fikst), a Re:

Build Manufacturing, LLC (Re:

Build) company is a growing product design and engineering consulting firm located in Wilmington, MA. We work with pioneering clients to develop their technology, design their products, and bring those products to production. Fikst's areas of expertise include biomedical instruments and consumables, microfluidics, specialty plastic design, optics, industrial automation, and design for manufacturing. We have extensive in-house laboratory and rapid prototyping capability including CNCs, 3D printers and laser cutters, all of which helps facilitate our ability to prototype and innovate fast.

Who is Re:

Build Manufacturing?

Re:

Build Manufacturing is a growing family of industrial and engineering businesses combining enabling technologies, operational superiority, and strategic M&A to build America's next generation industrial company. At Re:

Build we deploy deep expertise in engineering, operations management, and technology to supercharge the performance of our member companies. We leverage deep professional expertise and a candid, principled operating culture to drive differentiated outcomes. Ours is a fast-paced environment where individuals can stretch and be challenged to pursue their fullest potential.

Re:

Build was founded to pioneer a profitable model for the revitalization of US manufacturing. We've assembled a powerful set of complimentary capabilities and lines of business that enable us to pursue a wide range of end markets. Our acquired businesses are grounded in build-to-print and by-the-hour engineering and design services, and we're leveraging their combined expertise to migrate to increasingly sophisticated program development and production, as well as the generation of our own products.

Our unique set of capabilities lend themselves to highly complex systems and products, and we offer customers a range of services including product and systems design, automation, fabrication, assembly, and large volume contract manufacturing. Our customers span a wide array of industries including aerospace, defense, mobility, healthcare, pharma, biotech, clean tech, chemicals, energy, lifestyle, food production, and industrial equipment.

Who we are looking for

We are seeking a highly motivated and detail-oriented Quality System Engineer with a strong background in ISO 13485 and quality management systems. The ideal candidate will have at least five years of experience in managing quality systems, specifically in the medical device or regulated industry, and a passion for ensuring compliance with industry standards. This role requires someone with excellent leadership skills, capable of driving continuous improvement, managing audits, and aligning quality processes with overall business goals.

We are looking for someone who can collaborate across departments to uphold the highest standards of quality and compliance.

What you'll get to do

* Lead the quality management system (QMS):
Oversee the development, implementation, and maintenance of the QMS in accordance with ISO 13485.

* Manage compliance:
Ensure that all processes are compliant with regulatory and statutory requirements through regular audits and inspections.

* Drive continuous improvement:
Identify opportunities for quality process enhancements and lead initiatives to improve efficiency and compliance.

* Support design transitions to manufacturing:
Work with the product development consulting team to help transition prototype designs into controlled manufacturing processes.

* Collaborate with internal teams:
Work with cross-functional teams, including product development, manufacturing, and regulatory affairs, to ensure product quality and adherence to QMS procedures.

* Oversee audits and inspections:
Manage internal and external audits, prepare for regulatory inspections, and address any non-conformances or corrective actions.

* Train and mentor staff:
Provide training and guidance on quality system procedures, best practices, and regulatory requirements.

* Monitor performance metrics:
Track quality metrics, such as non-conformances and corrective actions, and report on QMS performance to senior leadership

What you bring to the Team

* Experience:

At least 5+ years of experience in quality management within a regulated industry, ideally in medical devices or a related field, with a deep understanding of ISO 13485 and other applicable regulatory standards.

* Education:

A Bachelor's degree in Engineering, Life Sciences, or a related technical field. An advanced degree or certifications (e.g., CQE, CQA) in quality management is a plus.

* Leadership and Communication:
Strong leadership skills with the ability to influence and work cross-functionally. Excellent written and verbal communication skills to convey complex quality concepts clearly and effectively.

* Technical Expertise:
Thorough understanding of quality management systems, regulatory audits, CAPA processes, risk management, and quality…