Whether a billion-dollar global diagnostics company or a handful of inventors forming a startup, every client we help cross the finish line relies on our reputation of expertise and quality. As a Quality Systems Associate at MDC Associates, you’ll play a key role in supporting our internal operations by maintaining our quality system documentation and performing document life cycle activities. This is your opportunity to acquire foundational experience with quality systems and start your path of growth at MDC in quality systems consulting. Join our fast-growing team as we scale up to meet the increasing demand of the medical diagnostics industry.
- Maintains all quality management system documentation, including process, supplier, purchasing, and compliance in conjunction with the Quality Systems team and Management
- Coordinates record management, document changes, and compliance reviews to support the quality system in conjunction with the Quality Systems team and Management
- Performs document life cycle activities, such as initiation, enumeration, review, approval, distribution, status, updates, etc.
- Ensures the compliance, efficacy, and quality of records by revising documents to meet required standards and by partnering with document creators to obtain necessary revisions
- Facilitates site records retention, performing records archiving and retrieval as needed
- Works in conjunction with the Quality Systems team to support client projects
- Forms a basic understanding of the company’s quality management system and processes to identify and close gaps and suggest improvements
- Actively participates in efforts to continuously improve the quality system
- Demonstrates consistent growth in the ability to maintain quality system documentation
- Bachelor’s degree in a related medical, science, or engineering discipline; or 3+ years of equivalent quality systems experience in a highly regulated industry
- Ability to prioritize work and manage multiple tasks
- Self-starter with the ability to work independently and collaboratively in teams
- Proficient with Microsoft Office suite of products
- Strong communication skills
Advanced Candidate Qualifications
- Experience with ISO 9001:2015 standards
- Experience managing electronic records
- Experience with quality management systems
- Experience of 13485:2016 and 21 CFR, a plus
For over 30 years, MDC has helped innovators and entrepreneurs bring in vitro diagnostics (IVD) and medical devices to market and impact the lives of millions of patients around the world. Our mission is to continue to support these innovators by applying our expertise in Regulatory Affairs, Quality Systems, Training, and other consulting services to help them launch new advances that promote and protect our global and local communities’ health. Learn more at www.mdcassoc.com.
By joining MDC, you will experience opportunities to grow your skillset and advance your career in a culture where we value everyone, and know that our success is tied to yours. Take the next step to explore an opportunity with MDC by applying for this position.
MDC Associates, Inc. is an Equal Opportunity Employer committed to a diverse workforce. MDC Associates, Inc. will not discriminate against any worker or job applicant based on race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, or membership in any other category protected under law.
Minimal travel expected
Vice President, Quality Systems
Our offices are within easy walking distance from the Beverly Depot, allowing for a green commute from Boston and the North Shore (Newburyport and Rockport lines).
Pay and Benefits
MDC Associates, Inc, offers competitive salaries and benefits, including health/dental, HRA, and 401k with a match. We also support an engaging work environment that provides everyone the opportunity and structure to learn and grow.