Job Description
Senior Quality Engineer
Our client is a medical device innovator develops precision-engineered technologies that improve patient and caregiver experiences in vascular access procedures. With multiple recent regulatory approvals and an expanding product pipeline, the organization is building momentum while maintaining the agility and visibility of a startup environment.
Job Description
This Senior Quality Engineer will be responsible for:
- Supporting and improving the Quality Management System (QMS)
- Partnering with R&D on design controls and product development activities
- Leading risk management activities in compliance with ISO 14971
- Investigating nonconformances, complaints, and CAPAs
- Managing supplier qualification, monitoring, and quality performance
- Conducting root cause investigations and product failure analysis
- Supporting process validation and manufacturing transfer activities
- Reviewing engineering changes for quality and regulatory impact
- Monitoring quality metrics and driving continuous improvement initiatives
- Supporting contract manufacturing operations and supplier relationships
- Assisting with internal audits, supplier audits, and inspection readiness
- Serving as a key quality resource for engineering and manufacturing teams
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.
The Successful Applicant
A Successful Senior Quality Engineer will have:
- 7+ years of medical device industry experience.
- 5+ years in Quality Engineering or Quality Assurance roles.
- Strong knowledge of ISO 13485, ISO 14971, FDA/QSR requirements, and medical device regulations.
- Experience with supplier qualification, supplier audits, and supplier quality management.
- Experience supporting CAPA, complaint handling, risk management, and nonconformance investigations.
- Hands-on validation experience including IQ/OQ/PQ and process validation.
- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
- Experience in Class II medical devices; startup experience is highly desirable.
What's on Offer
- Bonus opportunity based on level.
- Potential equity participation
- Direct exposure to executive leadership and company growth.
- 15 days PTO plus 7 paid holidays.
- Medical, dental, and vision coverage.
- 401(k) plan with future company match under consideration.
Apply today to be considered within 24 hours!
Contact Ashley Santos Quote job ref JN-082026-7089391
Job Summary
Sector: Engineering & Manufacturing
Sub Sector: Production, Manufacturing
Industry: Industrial / Manufacturing
Where: International
Contract Type: Permanent
Consultant name: Ashley Santos
Job Reference: JN-082026-7089391
Numbers & Facts
| Location | Miami, Florida |
| Job Type | Full-time |
| Industry | Staffing/Employment Agencies |
| Salary | $110,000–$145,000 Per Year |
| Company Size | 10,000 employees or more |
| Website | https://www.michaelpage.ca/ |
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.
Skills
- Biologyunmatched
- Continuous Improvementunmatched
- Contract Manufacturingunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- FDA Requirementsunmatched
- Failure Analysisunmatched
- ISO (International Organization for Standardization)unmatched
- Internal Auditunmatched
- Leadershipunmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Manufacturing Operationsunmatched
- Medical Equipmentunmatched
- Medical Treatmentunmatched
- Operational Supportunmatched
- Patient Careunmatched
- Performance Analysisunmatched
- Process Improvementunmatched
- Process Manufacturingunmatched
- Process Validationunmatched
- Product Designunmatched
- Product Developmentunmatched
- Quality Assuranceunmatched
- Quality Engineeringunmatched
- Quality Managementunmatched
- Quality Metricsunmatched
- Quality Monitoringunmatched
- Quality System Requirements (QSR)unmatched
- Regulationsunmatched
- Research & Development (R&D)unmatched
- Risk Managementunmatched
- Root Cause Analysisunmatched
- Startupunmatched
- Vendor/Supplier Evaluationunmatched
- Vendor/Supplier Managementunmatched
- Vendor/Supplier Quality Managementunmatched
- Vendor/Supplier Relationsunmatched
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