Highlights
Facilitate risk assessments and develop risk mitigation strategies using tools such as PFMEA and risk management frameworks. Minimum 2+ years of Quality Engineering experience within medical device manufacturing or a regulated engineering environment.
Numbers & Facts
| Location | Bethel, Connecticut |
| Job Type | Full-time |
| Industry | Staffing/Employment Agencies |
| Salary | $80,000–$103,000 Per Year |
| Company Size | 10,000 employees or more |
| Website | https://www.michaelpage.ca/ |
Description
Quality Engineer
Lead quality engineering support for product development, manufacturing, and continuous improvement projects. Drive implementation and optimization of quality systems, quality controls, and process improvements. Facilitate risk assessments and develop risk mitigation strategies using tools such as PFMEA and risk management frameworks. Lead root cause investigations, CAPA activities, and corrective action effectiveness reviews. Support and execute equipment, process, and product qualification and validation activities. Develop and maintain quality control plans, inspection strategies, and process monitoring systems. Implement and maintain statistical process controls and sampling methodologies. Ensure compliance with ISO 13485, FDA regulations, and internal quality standards. Participate in technical and design reviews as the quality representative. Serve as a subject matter expert in multiple quality disciplines. Collaborate with customers to resolve quality concerns, complaints, and product-related issues. Author validation protocols, reports, process deviations, and change notifications. Support manufacturing troubleshooting and process optimization activities. Develop, implement, and maintain metrology equipment and measurement systems. Conduct Gage R&R studies and analyze manufacturing and validation data. Approve nonconformance dispositions and manage quality documentation. Develop quality procedures and provide training across the organization. Support supplier quality activities, including audits and qualification efforts. Act as the quality lead on cross-functional new product introduction and acceleration programs.
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 or a related technical discipline. Minimum 2+ years of Quality Engineering experience within medical device manufacturing or a regulated engineering environment. Strong knowledge of ISO 13485 and FDA 21 CFR 820 quality system requirements. Experience with CAPA, nonconformances, root cause investigations, and risk management processes. Knowledge of validation and qualification methodologies for equipment, products, and manufacturing processes. Experience developing quality documentation, procedures, protocols, and reports. Working knowledge of statistical analysis tools and Minitab. Strong technical writing and communication skills. Ability to interact professionally with customers, suppliers, and cross-functional teams. Experience with SPC, inspection planning, and quality control methodologies. Exposure to supplier quality management and auditing is preferred. CQE, Six Sigma Green Belt, or Belt certifications are highly desirable. Experience mentoring team members and leading projects is a plus.
Permanent position. Salary range of $80,000 to $103,000. Work on innovative technologies that directly impact the medical device industry. Join a rapidly expanding organization with strong growth opportunities. Gain exposure to advanced manufacturing and cutting-edge engineering projects. Take ownership of high-visibility quality initiatives and strategic programs. Collaborate with talented technical teams in a fast-paced, innovation-driven environment.
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.