Responsibilities:
- Establish and enhance quality functions related to both Suntra’s QMS and to delivery of engineering services to Suntra’s clients
- Oversee the development and implementation of the company quality management system (QMS), ensuring adherence to regulatory standards, and driving continuous improvement
- Act as Suntra’s Quality representative on client engagements to ensure compliance with applicable QMS and regulatory standards
- Develop and maintain a robust QMS aligned with ISO 13485 and regulatory requirements
- Define the organization’s quality strategy and establish clear objectives
- Create and maintain QA training from onboarding to offboarding
- Work closely with engineering and other teams to integrate quality considerations into processes and client projects
- Prepare for and manage external audits and inspections
- Drive a culture of continuous improvement in quality processes
- Build and mentor a high-performing quality team consisting of both direct and indirect reports
- Implement and oversee CAPA (Corrective and Preventative Actions) system
- Refine finished product release process
- Support HHE (Health and Hazard Evaluations) for employee safety in the workplace
- Present Management Review on Metrics (NCMRs, CAPAs, Supplier Quality, Audits, etc.)
- Support Customer Communication Processes establishment
- Support Supplier Audits and Supplier Monitoring
We’re Looking For:
- Bachelor’s degree in science or engineering. (Master’s degree is a plus)
- Minimum 8 – 10 years of quality management experience within the medical device industry and with the product development process
- In-depth knowledge of FDA regulations, ISO 13485, and other quality standards related to the design of medical devices and equipment
- Proven track record of implementing and managing quality management systems
- Strong leadership, communication, and interpersonal skills
- Excellent problem-solving and decision-making abilities
- Ability to lead within ambiguity and pivot quickly in a rapidly changing environment
Why work with us:
- A comprehensive benefits package including Health Insurance with 100% company-paid Dental, Life and Disability insurance
- Three weeks’ vacation, unlimited sick time, plus10 paid holidays
- Monthly lunches and socials, “Bagel Tuesday”
- Hybrid work options
At Suntra MedTech Solutions, we’re driven by a simple but powerful idea: to make a measurable difference in patients’ lives by partnering with medtech companies to bring life-changing technologies to market. Formerly known as Sunrise Labs, we’ve spent over 30 years building a reputation for excellence. Now, as Suntra, we’re expanding that legacy with a broader, more integrated approach.
Our teams work at the intersection of consulting, engineering, and innovation, helping clients solve complex challenges from the earliest spark of an idea through to commercial readiness. Whether we’re uncovering strategic gaps, scaling an established pipeline, or designing with patients and providers in mind, we do it with rigor, heart, and purpose.
If you want to work where your expertise is valued, your curiosity is encouraged, and your work has real-world impact, Suntra is the place to grow. We’re building the future of medtech—come help us lead it.
We’re in southern New Hampshire where the mountains, lakes, and oceans are our playground, and Boston is just down the road. We offer great benefits and competitive salaries based on experience.
We do not accept resumes from staffing agencies or search firms unless a valid search agreement is in place with the agency for a specific position.