Resonetics · 19 hours ago
Quality Engineer II
Nashua, NH
Full-time
Onsite
Entry, Mid Level
$65K/yr - $102K/yr
2+ years expResonetics is a global leader in advanced engineering and micro manufacturing in the medical device industry. They are seeking a Quality Engineer II to apply advanced Quality Engineering techniques, conduct projects with moderate to high technical responsibility, and ensure compliance with industry standards and regulations.
Life ScienceManufacturingMedical Device
No H1B
Responsibilities
Demonstrates strong proficiency in applying various tools and methods to identify and realize new product or process introductions (ex. QMS, product related), and business improvements
Leads and contributes to the application of various risk management and risk mitigation tools and practices
Leads and/or contributes to root cause investigations using various problem-solving techniques and tools and assesses effectiveness of corrective actions
Conducts and supports the development of test methods in equipment, process, and product qualifications/validations
Develops, implements, and/or maintains process Quality control plans are in accordance with product risk level and are followed
Develops, implements and/or maintains process controls using appropriate techniques and tools (ex. Statistical process controls, statistical inspection sampling)
Supports all levels of Design Controls per ISO 13485:2016 and QSR 21 CFR 820
Participates in design/technical reviews as appropriate
Lead QE on product development projects
Interprets standard and non-standard sampling plans
May act as a subject matter expert (SME) in at least one routine Quality area
Liaising with customer quality personnel to resolve issues and Customer Complaints
Generating process deviations, Customer Change Notices, validation protocols & reports
Assisting with troubleshooting of production and product development processes
Leading development of metrology equipment
Developing and maintaining quality/control plans
Ensuring Quality Management Systems procedures and appropriate regulations and industry standards are being utilized throughout the product development and process development processes
Developing Risk documentation in compliance with the QMS and regulatory standards, such as PFMECAs
Conducting Gage R&R studies
Resolving Corrective and Preventive Actions
Developing Quality Procedures and conducting training to all personnel as appropriate
Approving Nonconformance disposition
Analyzing production and validation data
Working on continual improvement and process assessment projects as assigned
Author protocols or provides support in performing qualification validation protocols in support of design control deliverables
As a lead Quality Engineer on development projects, directly contribute and/or provide guidance to others to establish appropriate Design History File / Device Master Record documentation and provide detailed planning for product builds
Support Equipment Calibration and Maintenance per the applicable procedures
Qualification
Required
2+ years' experience in a Quality Engineering role in Manufacturing environment with preference in experience with Medical Device or regulated environment
Ability to create job-related documentation for quality purposes
Familiarity with ISO 13485 standards and 21 CFR 820 regulations
Demonstrated technical writing and communication skills
Working knowledge of Statistical software and/or Minitab
Bachelor's degree or equivalent experience
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
Preferred
CQE and/or Six Sigma Green or Black belt
BS degree: Physics, Optics, Mechanical, Chemical, Plastics, Engineering preferred
Strong attention to detail and satisfactory organizational skills
Able to self-manage project tasks
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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