Candela Medical · 17 hours ago
Senior Quality Engineer
Marlborough, MA
Full-time
Onsite
Mid, Senior Level
2+ years expCandela Medical is seeking a Senior Quality Engineer responsible for executing operational quality activities and managing improvements to product quality. The role involves analyzing quality data, leading product quality issue resolutions, and ensuring compliance with relevant regulations.
Medical Device
Hiring Manager
Hannah Chadwick (Elrick)
Responsibilities
Publish regular product quality metrics to satisfy Monitoring/Analysis of Quality Data requirements, including complaint rate reporting
Execute processes and triggers for review, analysis, and rapid/effective root cause investigation of product/process quality data
Determine annual complaint rate targets and execute relevant planning/project activities to achieve
Provide SME-level guidance for the use of basic quality tools, sample size determination, and the use of Design of Experiments in qualification and/or investigation activities
Accountable to ensure an effective validation process to preserve field safety and quality performance
Remain current on technical/technological advances and contemporary thinking in disciplines that are complementary to the direction of Candela, as well as industry trends
Establish QA’s functional role within both the Design Transfer and Product Transfer processes, most specifically around input to PFMEA activities with Supplier Quality to ensure delivery of consistently safe/efficacious devices
Lead efforts to resolve field product quality issues
Ensure equipment, tooling, and fixture control, including calibration, preventive maintenance, documentation, qualification, and field communication across product lines
Use knowledge of applicable regulations to manage changes in accordance with Candela QMS, FDA, and other applicable (global) regulations
Accountable for the effective and timely execution of product quality improvement projects, including project status and data reviews with cross-functional teams
Contributor and/or reviewer of engineering product change requests or modified process characteristics, including manufacturability, quality control, serviceability, testability, reliability, and conformance to product requirements
Responsible for identifying and implementing improvements that support the company's goals and objectives
Must be able to prioritize responsibilities to maintain a balance of support in all areas and execute projects with clear objectives/deliverables
Other duties as assigned by supervisor
Qualification
Required
Bachelor's degree in an engineering discipline, plus 2 years of experience in a product quality role in a regulated environment
Hands-on experience in resolving product quality issues in a matrix organization
Experience leading quality and other cross-functional teams
Good knowledge of ISO13485
Working knowledge of FDA QMSR
Experienced in performing root cause investigations, including advanced root cause analysis tools
Skilled in applying FMEA methodology to mitigate product risk
Working knowledge of risk management standard ISO 14971
Working knowledge of an electronic PLM system (such as Oracle)
Ability to work in collaboration with cross-functional teams
Capability to plan and organize own workload based on organization needs
Proficient in the use of the Microsoft Office Suite (Word, Excel, PowerPoint, etc.)
Working knowledge of Project Management principles
Ability to work with minimal supervision
Ability to prioritize workload to meet deadlines and work independently
Attention to detail
Quality assurance practices and procedures
Strong written/verbal communication skills, including presenting to senior management
Preferred
Opto-electro-mechanical assemblies and knowledge of lasers are a plus
Knowledge of 3D modeling/drawings (SolidWorks) is a plus
Engineering or Technical Degree
Company
Candela Medical
Candela’s brand values of Science, Results, and Trust guide its commitment to safety, efficacy, reliability and strengthening the longstanding partnerships of trust established with physicians, their practices and the patients they treat.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Ernie Orticerio
Chief Financial Officer
Robert Blood
Executive Vice President, Chief Legal Officer and General Counsel
Company data provided by crunchbase