Senior Quality Systems Specialist

Synchron; New York (NY); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Subsidized medical and dental insurance

Life insurance

401k

Unlimited PTO

Flexible Spending Account

Commuter benefits for NY employees

Job summary

A leading medical device company in New York is seeking an experienced Senior Quality Systems Specialist. The role involves managing Document Control processes, administering the Arena eQMS, and driving quality system development. Ideal candidates will have over 5 years of experience in FDA regulated industries and a strong knowledge of medical device regulations. This position offers a salary range of $120,000 to $160,000 along with comprehensive benefits and a culture focused on quality and collaboration.

Qualifications

• 5+ years of experience in an FDA regulated environment.
• Knowledge of medical device Quality Management Systems and applicable regulations.
• Experience with electronic Quality/Document Management Systems (preferably Arena).

Responsibilities

• Own Document Control process and educate personnel.
• Administer Arena eQMS and manage configurations.
• Drive development of Synchron SOPs adhering to compliance standards.
• Conduct audits and support Quality Management Reviews.

Skills

Detail-oriented

Process-driven

Excellent time management

Effective communication

Proactive

Education

Bachelor's degree

Tools

Arena eQMS

Microsoft suite (Word, Excel, Teams, PowerPoint)

Adobe

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 with a passion for problem-solving and doing right by our patients. If this sounds like you, then we invite you to apply!

Job Location

New York, NY (on-site)

Job Responsibilities

• Document Control - Own the Document Control process including processing change requests and change orders for documents in Synchron’s eQMS (Arena), identifying improvement opportunities for the process, and educating company personnel on Document Control best practices
• eQMS Administration - Administer and manage the Arena eQMS including configuration, account allocation, and license management
• Training Management - Own the Personnel Training process in the QMS including determining initial Quality Training needs, assigning employee Quality Training Plans, monitoring training completion, and maintaining training records and certifications
• QMS Process Development - Drive the maintenance and development of existing and new Synchron SOPs to meet Synchron business needs, current regulations, and standards by employing industry experience and knowledge of QMSR, GLP, GMP and FDA compliance standards
• Quality Process Execution - Own the execution of processes associated with handling of clinical 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 records in accordance with internal procedures
• Management Reviews - Support Quality Management Reviews, including taking meeting minutes, preparing data and information for the review, and publishing the review in the QMS
• Audits - Assist with audit preparation and execution, resolution of audit findings, interactions with auditors through all stages of audits, and perform or oversee contractors for audits of critical suppliers
• 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 sciences but we are open to different backgrounds
• 5+ years of experience working within a Quality Management System in an FDA regulated environment (e.g. medical device, pharmaceutical, or biotech)
• Knowledge and understanding of medical device Quality Management Systems and applicable regulations and standards including 21 CFR 820 and ISO 13485:2016
• Experience administering an electronic Quality/Document Management System (preferably Arena)
• Demonstrated ability to perform detail-oriented work with a high degree of accuracy
• Excellent time 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

Nice-to-have Qualifications

• Experience with class III medical devices in an area such as neuromodulation, vascular devices, or cardiac rhythm management
• Experience participating in quality inspections and performing supplier quality audits
• Experience supporting 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.