Resonetics · 7 hours ago
Sr. Quality Engineer
Nashua, NH
Full-time
Onsite
Mid, Senior Level
$78K/yr - $124K/yr
5+ years expResonetics is a global leader in advanced engineering and micro manufacturing within the medical device industry. The Sr. Quality Engineer will implement and maintain the Quality Management System (QMS) to ensure compliance with regulatory requirements and support product development activities related to medical devices.
Life ScienceManufacturingMedical Device
No H1B
Responsibilities
Responsible for assuring product quality, safety and effectiveness, and conduct failure investigations of customer complaints, as required
Ensure project teams are utilizing Resonetics Quality Systems and appropriate regulations and industry standards throughout the product development process
Collaborate with the development engineering team(s) to create and/or update documentation to support Design Controls
Author protocols or provides support in performing qualification validation protocols in support of design control deliverables
Conduct risk assessments of the design to determine ability to function as intended. Responsible for completion of risk analysis and mitigating actions
Responsible for timely Corrective and Preventative Actions (CAPA), change control and notification, internal and supplier audits, product release, document control, design control process and design history files (DHF), device master records, etc
As a lead Quality Engineer on projects, directly contribute and/or provide guidance to others to establish appropriate Design History File / Device Master Record documentation and provide detailed planning for clinical, pilot production and scale-up builds
Interact with customer and supplier companies in a professional manner; proactively communicates with them to ensure an ongoing two-way exchange of information. Auditing and qualification of new suppliers may be required
Help create and implement and maintain product/process specifications, standards, and procedures to support QMS implementation and documentation. This involves writing and revising documents as necessary
Maintain QMS to ensure full compliance to all quality and regulatory requirements
Manage the Document Control process and ensure all steps of this process are performed
Provide statistically valid sampling plans when required
Work closely with engineering in understanding, developing and executing statistically designed experiments
Manage Training program, including maintenance of training records and monitoring training compliance
Procure and maintain external standards
Develop incoming, in-process, and final inspection and quality plans
Maintain and/or support maintenance of the Non-Conforming Material and Corrective and Preventive Action System, including NCMR (disposition, review, and approval), CAPA (initiation, review, verification, and effectiveness check), Complaint Handling (handling, investigation, and reporting) to ensure timeliness of actions and tracking metrics to support management review
Collaborate with all internal groups and customers to help determine root cause of customer issues, Complaints, and CAPAs
Support Equipment Calibration and Maintenance per the applicable procedures. Maintain accurate calibration records in accordance with internal requirements
Maintains detailed documentation throughout all phases of research and development, often leading documentation of user needs, product requirement and risk / test planning and execution activities
Assist in Incoming and Final Acceptance Activities by ensuring that proper documentation is maintained and preparing metrics as appropriate
Assist in the preparation of Management Review presentations and maintain accurate records of such
Works closely with all team members in onboarding and assessment of new suppliers and oversees supplier quality program (supplier files, approved supplier list; supplier audits, supplier performance metrics, etc.)
Ensures that all work satisfies the requirements of the company's Quality Manual. Continually looks for improvement and compliance improvement opportunities
Complete projects in a timely manner and consistent with company objectives
Mentor junior engineers on quality system requirements
Any other duties as assigned
Qualification
Required
5+ years of experience in a Quality Engineering role
Bachelor's degree or equivalent experience
Demonstrated technical writing and communication skills
Strong attention to detail, organization, and verbal and written communication skills
Ability to interact with client companies in a professional manner
Demonstrated ability to lead product verification & validation activities
Organized and able to self-manage project tasks
Proficiency in use of Word, Excel, and PowerPoint
Ability to work under pressure, handle multiple projects, and meet aggressive deadlines
Ability to read and understand regulations, standards, and procedures
Preferred
Experiences with analytical instrument calibration preferred
Company
Resonetics
Resonetics provides laser micromachining contract manufacturing solutions and systems for the life sciences and other high precision.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
$1.12BKey Investors
The Carlyle GroupRegatta Medical
2021-12-03Private Equity· $1.12B
2018-02-01Private Equity
2014-10-22Acquired
Leadership Team
Todd Trapp
Chief Financial Officer
D
David Rezac
Global Vice President, AGILE Product Development
Recent News
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Company data provided by crunchbase