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Quality Engineer III - Medical Device - Danbury, CT

Michael Page International

  • Danbury, CT
  • 16 days ago
  • $65,000–$100,000 Per Year
  • Full-time

Highlights

Provide technical leadership, mentorship, and quality expertise to support organizational growth and operational excellence. Lead quality engineering initiatives across new product development, manufacturing, and continuous improvement projects.
Michael Page International

Numbers & Facts

LocationDanbury, CT
Job TypeFull-time
IndustryStaffing/Employment Agencies
Salary$65,000–$100,000 Per Year
Company Size10,000 employees or more
Websitehttps://www.michaelpage.ca/

Description

Quality Engineering Lead

Lead quality engineering initiatives across new product development, manufacturing, and continuous improvement projects. Drive risk management, root cause investigations, CAPA activities, and process improvement efforts. Develop and execute equipment, process, and product validations while ensuring regulatory compliance. Create and maintain quality plans, procedures, technical documentation, and validation reports. Apply statistical analysis, SPC, and data-driven methodologies to enhance product and process performance. Partner with customers, suppliers, and cross-functional teams to resolve quality issues and improve outcomes. Ensure compliance with ISO 13485, FDA regulations, and internal quality system requirements. Provide technical leadership, mentorship, and quality expertise to support organizational growth and operational excellence.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, or a related technical discipline. Minimum of 2 years of Quality Engineering experience within a medical device, regulated manufacturing, or similar engineering environment. Working knowledge of ISO 13485 and FDA 21 CFR 820 quality and regulatory requirements. Experience creating and maintaining quality documentation, validation protocols, and technical reports. Strong problem-solving, technical writing, and communication skills. Experience with statistical analysis tools, SPC methodologies, and software such as Minitab. Ability to collaborate effectively with customers, suppliers, and cross-functional teams. Experience supporting supplier audits, qualification activities, and quality system improvements. CQE certification and/or Six Sigma Green Belt preferred. Strong organizational skills with the ability to manage multiple projects independently.

Join a growing organization investing heavily in technology and innovation with the medical device environment. Take ownership of high-visibility quality and continuous improvement projects. Work directly with customers, engineering teams, and senior technical leaders. Gain exposure to advanced manufacturing and regulated product development environments. Enjoy strong opportunities for career growth, technical development, and leadership progression. Comprehensive benefits package.

About Company

Michael Page is one of the world's leading professional recruitment consultancies, specializing in the placement of candidates in permanent, contract, temporary and interim positions with clients around the world. Our business was established in Canada in 2005 when we opened our Toronto office. Our role is to work with employers and job seekers to facilitate a successful match. This can range from advising a global company on a candidate sourcing strategy to helping a job seeker find their dream job. In Canada, we focus on recruiting for the following areas: Banking and financial services Digital and e-commerce Engineering and manufacturing Finance and accounting Human resources Information technology Marketing Oil and gas Procurement and supply chain Property and construction Sales An Established Brand The Group has established a leading presence in many of the key markets for professional recruitment around the world and has positioned itself in certain other markets, which offer the opportunity for future growth. Within its current largest markets, Michael Page has also built a regional presence, including in the UK, France and Australia. Consequently, the Michael Page brand is among the most widely recognized brands in the professional recruitment industry. A Market Leader The role of a recruitment consultancy is to act as an intermediary, identifying and sourcing suitably qualified candidates on behalf of its clients. Candidates are recruited either for permanent or contract positions (typically for a fixed term) or on a temporary basis. Within the overall recruitment industry, the market for professional recruitment services is a specialist sector which has developed more recently. Michael Page is widely recognized as leading the development of this market around the world. Learn the benefits of working with Michael Page yourself. Submit your resume or contact a Michael Page recruitment consultant today.

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