Quality Systems Engineer - QSE II

 Who is Fikst Product Development?

Fikst, a Re:Build Manufacturing company, is a dynamic product development and engineering consulting firm located in Wilmington, MA. We work with pioneering clients to develop their technology, design their products, and bring those products through to production. Fikst's areas of expertise include industrial products, robotics, biomedical instruments and consumables, microfluidics, specialty plastic design, optics, and design for manufacturing. We have extensive in-house laboratory and rapid prototyping capability including CNCs, 3D printers and laser cutters, which help facilitate our ability to prototype and innovate fast. As part of Re:Build Manufacturing, we are able to collaborate with other member sites and leverage a greater network of capabilities such as composites, industrial design, and software.

Who is Re:Build Manufacturing?

Re:Build Manufacturing is rekindling America's manufacturing base and creating meaningful, sustainable jobs in areas that have been deindustrialized over the past 20-30 years. Our strategy is to employ technology, systems, deep financial resources, and best management practices to compete and win as manufacturers in the global market. We are NOT private equity. We do not buy companies with the intention of selling them. Over the next decades, we want to make a difference in the US Manufacturing economy and the communities in which we operate. We believe in the power of people and the long-term competitive advantage that can be derived from helping our employees achieve their fullest potential.

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.
• 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 control. Experience with document control systems and quality software tools is a plus. 
• Analytical Mindset: Strong problem-solving skills with an analytical approach to identifying risks, inefficiencies, and opportunities for continuous improvement within the quality management system. 
• Attention to Detail: Meticulous attention to detail, ensuring all processes, documentation, and audits meet regulatory requirements and industry best practices. 
• Team Player: A collaborative approach with a passion for mentoring and training others in quality best practices, fostering a team culture focused on compliance and continuous improvement. 
• Commitment to Excellence: A results-driven attitude with a genuine commitment to upholding the highest quality standards and ensuring company success through rigorous adherence to quality and regulatory requirements.

The BIG payoff

We are a company that is going to make a difference in the industries and the communities in which we choose to operate.

Every employee of Re:Build will share ownership in the company and share in the financial rewards of the success we achieve together, at all company levels!

We want to work with people that reflect the communities in which we operate

Re:Build Manufacturing is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, marital status, parental status, cultural background, organizational level, work styles, tenure and life experiences. Or for any other reason.

Re:Build is committed to providing reasonable accommodations for qualified individuals with disabilities in our job application procedures. If you need assistance or an accommodation due to a disability, you may contact us at [email protected] or you may call us at 617.909.6275.