Quality Specialist - Medical Device Manufacturer
Michael Page International
- Elk Grove Village, IL
- 1 day ago
- $60,000–$80,000 Per Year
- Full-time
Highlights
Bachelor's Degree (Engineering-related preferred) 2+ years of manufacturing experience within quality Understanding of ISO 9001 Experience with electro-mechanical processes is preferred Medical device experience Combination device experience is preferred Experience working with capital equipment Experience working with sterile products is preferred Understanding of ISO 14971 and UL 60601 is preferred CQE certification is preferred Six Sigma belt is preferred Sponsorship is not provided. Sector: Engineering & Manufacturing Sub Sector: Quality, Technical Industry: Industrial / Manufacturing Where: Elk Grove Village Contract Type: Permanent Consultant Name: Ben Aldrich Job Reference: JN-092026-7100199.
Numbers & Facts
| Location | Elk Grove Village, IL |
| Job Type | Full-time |
| Industry | Staffing/Employment Agencies |
| Salary | $60,000–$80,000 Per Year |
| Company Size | 10,000 employees or more |
| Website | https://www.michaelpage.ca/ |
Description
Product Review & Release
Review Device History Records (DHRs), manufacturing documentation, inspection data, and quality records to confirm products meet release requirements. Perform final quality review and disposition of production lots in accordance with established procedures and regulatory standards. Verify completion of all required manufacturing, testing, inspection, and labeling activities before product release. Identify and escalate quality concerns, deviations, or nonconformances that could affect product acceptance or release decisions. Support investigations and corrective actions related to product release issues.
Complaint Management & Investigation
Review, document, and process customer complaints in compliance with established quality and regulatory procedures. Assess complaints for completeness, risk level, investigation needs, and potential regulatory reporting requirements. Participate in complaint investigations to determine root cause and recommend corrective actions when necessary. Analyze complaint trends and performance data to identify recurring issues and emerging quality concerns. Escalate significant quality events and potentially reportable issues to Quality and Regulatory teams. Maintain accurate, complete, and compliant complaint documentation and records.
Internal & Supplier Audits
Conduct internal and supplier audits in accordance with approved audit schedules and procedures. Evaluate quality management system processes for compliance with ISO 13485, ISO 14971, FDA requirements, and internal standards. Document audit observations, findings, and opportunities for continuous improvement. Verify implementation and effectiveness of corrective actions resulting from audit findings. Support audit readiness initiatives, regulatory inspections, and ongoing compliance activities.
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 (Engineering-related preferred) 2+ years of manufacturing experience within quality Understanding of ISO 9001 Experience with electro-mechanical processes is preferred Medical device experience Combination device experience is preferred Experience working with capital equipment Experience working with sterile products is preferred Understanding of ISO 14971 and UL 60601 is preferred CQE certification is preferred Six Sigma belt is preferred Sponsorship is not provided
What's on Offer
Base salary between $60k-$80k Health, dental, vision 401(k) matching 3 weeks PTO 4% annual bonus incentive
Job Summary
Sector: Engineering & Manufacturing Sub Sector: Quality, Technical Industry: Industrial / Manufacturing Where: Elk Grove Village Contract Type: Permanent Consultant Name: Ben Aldrich Job Reference: JN-092026-7100199
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.