This range is provided by ACE Partners. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
Direct message the job poster from ACE Partners.
Senior Consultant | Regulatory Affairs & Quality Assurance | United States
The Quality Assurance Associate will support the Quality Manager in maintaining and improving the Quality Management System (QMS), managing vendor and internal processes, and ensuring compliance with regulatory standards. This role requires a hands-on contributor with strong organizational skills, an ability to manage multiple priorities, and a drive to succeed in a fast-paced, entrepreneurial environment.
Key Responsibilities:
1. Maintain and improve the effectiveness of the QMS, ensuring compliance with ISO 13485, ISO 14971, MDR, and FDA requirements.
2. Manage day-to-day QA activities, including supplier audits, documentation updates, and manufacturing oversight.
3. Assist with notified body and internal audits, as well as regulatory submissions for CE mark and FDA approvals.
4. Handle Post Market Surveillance activities, including customer complaints, trend analysis, and corrective actions.
5. Collaborate with suppliers to ensure validation and risk management meet regulatory standards.
6. Evaluate manufacturing and labeling changes for regulatory compliance and product quality impact.
7. Monitor global quality regulations, advising on compliance updates and their implications.
8. Support cross-functional teams in achieving quality objectives and compliance milestones.
Required Skills & Experience:
1. Bachelor’s degree in Engineering or Science; certifications in ISO 13485 or as a Lead Auditor preferred.
2. 4+ years of QA experience in the medical device industry, with expertise in ISO standards and EU MDR.
3. Proven ability to manage complex projects to deadlines and work collaboratively across teams.
4. Strong problem-solving and communication skills, with attention to detail and a proactive mindset.
This is an exciting opportunity to join a dynamic team, driving quality excellence in the medical device industry while advancing your career in a supportive environment.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Legal and Quality Assurance
Industries
Medical Equipment Manufacturing
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