Quality Systems Manager

Quality Systems Manager

Vacancy expired!

100% Remote

We have an excellent job opportunity available as a Quality Systems Manager!

This role is expected to last 6 months.

We can facilitate w2 and corp-to-corp consultants. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.

Responsibilities of the Quality Systems Manager:

• Audit and perform gap assessments on the Quality Management Systems
• Develop Quality plans for integration of new entities into the Align QMS
• Fluent in computer skills and, at a minimum, the use of Microsoft Office Word, Microsoft Office Excel, Microsoft Office PowerPoint and Microsoft Office Project
• Mange and implement new quality initiatives within the site including the implementation of Corporate Policies and Procedures
• Guide functional & cross-functional teams in the definition of core quality system processes
• Assist in maintenance of an ISO 13485:2016, EU MDD/MDR, FDA 21 CFR Part 820, compliant Site Quality Management System
• Conduct Quality Systems audits and assist in training/guidance to other auditors
• Assist with preparation and hosting of external Quality System inspections
• Managing internal audit, training, document control and records personnel

Requirements of the Quality Systems Manager:

• ISO 13485 and MDSAP auditor experience, Lead Auditor certification or training preferred
• Knowledge of US and International laws and standards that apply to the medical device industry including FDA Quality Systems Regulations, ISO 13485, MDD, EU MDR/IVDR, Canadian MDR, Japan PMDA as well as ANVISA requirements
• Software as A Medical Device (SaMD) experience preferred
• Creative problem-solving skills with exceptional verbal and written communication skills, and the ability to mentor others in Quality Management Systems
• Minimum 6 years of experience in medical device environment

Please be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an eglifesciences.com email address and never provide personal or financial information to anyone who is not clearly associated with EG Life Sciences. If you have any indication of fraudulent activity, please contact

Job ID: 375352

About EG Life Sciences:

Founded in 2010, EG Life Sciences is a national professional services firm that delivers strategic consulting and innovative solutions for the pharmaceutical, biologic, medical device, and diagnostic industries. We provide tailored services to clients seeking to manage challenges, improve time-to-market, and fine-tune clinical development and operations. Our team is comprised of dedicated professionals and FDA-regulated industry specialists, each averaging over 20 years of related experience. This combination of services and team members enables us to quickly deliver value-driven life sciences consulting, project management and leadership, and customized project-based solutions.

Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a

$1,000 referral check!