Sr. Quality Engineer - Medical Equipment - Hollywood, FL
Michael Page International
- Hollywood, Florida
- 1 day ago
Highlights
Experience with Class II medical devices, vascular access products, sterile single-use devices, sterilization validation, or ASQ CQE/CQA certifications preferred. Strong knowledge of 21 CFR Part 820/QSR, ISO 13485, ISO 14971, EU MDR, CAPA, complaint handling, supplier controls, and design controls.
Numbers & Facts
| Location | Hollywood, 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/ |
Description
Job Title
Drive quality excellence for innovative medical devices.
About Our Client
This organization develops innovative medical devices focused on improving patient care and clinical outcomes. Operating in a highly regulated environment, the company combines engineering excellence with a commitment to quality, compliance, and operational performance.
Job Description
Supporting new product development activities, design controls, supply chain initiatives, and continuous improvement of the Quality Management System.
Providing quality engineering support for process characterization, process validation, manufacturing transfers, and product or process changes.
Managing risk management activities, including hazard analyses, FMEAs, risk evaluations, and risk management documentation in accordance with ISO 14971.
Applying risk-based decision-making to balance regulatory compliance, product quality, patient safety, and business objectives.
Developing and reviewing validation protocols, validation reports, sampling plans, inspection methods, and supporting objective evidence.
Leading investigations related to nonconformances, deviations, supplier quality issues, complaints, and CAPA activities, including root cause analysis and effectiveness verification.
Overseeing supplier quality activities, including supplier qualification, audits, performance monitoring, SCAR management, and Approved Supplier List maintenance.
Participating in audits, regulatory inspections, training initiatives, quality metric reviews, and continuous improvement programs to enhance quality and operational performance.
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
Bachelor's degree in Engineering, Life Sciences, or a related scientific/technical discipline; Master's degree preferred.
Minimum 7 years of experience within the medical device industry.
Minimum 5 years of quality engineering or quality assurance experience in a regulated medical device environment.
Strong knowledge of 21 CFR Part 820/QSR, ISO 13485, ISO 14971, EU MDR, CAPA, complaint handling, supplier controls, and design controls.
Experience with supplier quality engineering, supplier audits, supplier qualification, SCAR management, and supplier performance improvement.
Experience with process validation, test method validation, DOE, SPC, GR&R, statistical sampling, process capability studies, and change control.
Proficiency with Minitab or similar statistical analysis software and strong technical writing and problem-solving skills.
Experience with Class II medical devices, vascular access products, sterile single-use devices, sterilization validation, or ASQ CQE/CQA certifications preferred.
What's on Offer
Competitive salary and potential for salary growth
Comprehensive benefits package, including health insurance, retirement plans, and vacation/sick leave
Opportunities for professional development and career advancement
A positive work environment that values collaboration and innovation
Work-life balance and flexible scheduling options
Access to cutting-edge technologies and resources
Engaging and challenging projects that foster skill development
Supportive and inclusive company culture
Networking opportunities within the industry
Potential for performance-based bonuses or incentives.
Interested? Apply today.
Contact Olivia Rose Quote job ref JN-102026-7133028
Job Summary
Sector: Engineering & Manufacturing
Sub Sector: Quality, Technical
Industry: Industrial / Manufacturing
Where: Hollywood
Contract Type: Permanent
Consultant name: Olivia Rose
Job Reference: JN-102026-7133028
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.