Job Description
Job Description
About the Job
We are seeking an experienced Senior Quality Systems Specialist to join Synchron’s Quality team. This is an amazing opportunity to shape the future of Synchron’s Quality Management System (QMS) and contribute to the Culture of Quality at the company. We are looking for candidates with experience working within FDA regulated industries (preferably medical devices) and who have experience performing document control within an eQMS (preferably Arena). The ideal candidate will be detail-oriented, process-driven, and comfortable working cross-functionally in a growing company with evolving needs. Synchron is a “patient first” company full of mission-driven people. We are looking for someone who shares our passion for problem-solving and doing right by our patients. If this sounds like you, then we invite you to apply and join the team!
Job Location
New York, NY (on-site). Travel is generally not expected but may be needed infrequently for supplier audits.
Job Responsibilities
- Document Control
- Own the Document Control process, including processing change requests and executing change orders for documents inSynchron’seQMS(Arena),identifyingimprovement opportunities for the process, and educating company personnel on Document Control best practices
- eQMSAdministration
- Administer and manage the Arena electronic Quality Management System including configuration, account allocation, and license management
- Training Management
- Own the Personnel Training process in the QMS, includingdetermininginitial Quality Training needs, assigning employee Quality Training Plans, monitoring training completion,maintainingtraining records and certifications, anddeterminingaccess to theeQMSand development tools for new hires
- QMS Process Development
- Drivethe maintenance and development of existing and new Synchron SOPs/documentation to meet Synchron business needs, current regulations, and industry standards by employing industry experience and knowledge of QMSR, GLP, GMP and FDA compliance standards
- Quality Process Execution
- Own the execution of processes associated withhandling ofclinical product, including incoming inspection, inventory management, product distribution, and product returns
- Support processes including Design Control, Change Management, CAPA, Product Feedback, and Nonconformances by guiding project teams to develop recordsin accordance withinternal procedures
- Support non-product software tool assessments and validations related to the QMS
- Management Reviews
- Support Quality Management Reviews, including taking meeting minutes, preparing data and information for the review, and publishingthereview in the QMS
- Audits
- Assistwith audit preparation and execution, resolution of audit findings,interfacewith auditing groups and inspectors through all stages of audits, and perform or oversee contractorsforaudits of critical suppliers
- General
- Use continuous improvement mindset to improve quality tools and processes
- Use creative problem solving to partner with cross-functional team members to respond to and resolve issues
- Foster a culture of quality through collaboration, partnership, teamwork, and a drive for change and continuous improvement
- Perform other duties and responsibilities as assigned
Required Qualifications
- Bachelor’s degree, preferably in the sciencesbut we are open todifferent backgrounds
- 5+ years of experience working within a Quality Management System in an FDA regulated environmente.g.medical device,pharmaceutical,orbiotech
- We are open to candidates withvarying levels of experiencesoif you believe your skillset aligns withthe rolewestillencourage you toapply
- Knowledge and understanding of medical device Quality Management Systems and applicable regulations and standards including 21 CFR 820 and ISO 13485:2016
- Experience using an electronicQuality/DocumentManagementSystem (preferably Arena)
- Demonstrated ability to perform detail-oriented work with a high degree of accuracy
- Excellenttime management,organizational,and planning skills
- Effective written and oral communication skills
- Possesses initiative and is proactive
- Must work effectively within teams with rapidly changing priorities
- Builds productive internal and external working relationships
- Knowledge of the Microsoft suite (i.e.Word, Excel, Teams, PowerPoint, etc.) and Adobe
Desired Qualifications
- Experience with class III medical devices in an area such as neuromodulation, vasculardevicesor cardiac rhythm management
- Experienceparticipatingin quality inspections and performing supplier quality audits
- Experiencesupporting investigational devices undergoing clinical trials
- ISO 13485:2016 Lead Auditor Certification
Compensation
The base salary range for this role is $120,000– $160,000, depending on experience, skills, and qualifications. In addition to base pay, this role may be eligible for discretionary bonuses and/or equity grants subject to board approval and company policy.
Work Authorization Notice
Synchron hires only individuals who are authorized to work in the United States. At this time, visa sponsorship is not offered for this role.
Benefits (for W-2, full-time, exempt employees in the US only) ***Intern positions not eligible
- Subsidized medical and dental insurance coverage for you and your dependent(s)
- Life insurance, short-term disability, long-term disability
- 401k
- Discretionary unlimited PTO
- Flexible Spending Account for you and your dependent(s), with eligible plan elections
- Commuter benefits for NY employees
Equal Employment Opportunity (EEO)
Synchron is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and provide equal employment opportunities without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other characteristic protected by applicable law.
If you need a reasonable accommodation during the application or interview process, please let us know.
Join Us
At Synchron, you will be part of a transformative mission and you will work alongside driven people who believe in the power of collaboration and innovation to make a lasting impact. If you are excited to stretch your skills and contribute to something meaningful, apply and now and build the future with us.