General Summary

The Quality Engineer is responsible for participating in and executing operational quality activities. This position is also responsible for planning, implementing, and managing improvements to product quality through process and other types of changes.

Primary Responsibilities
• Publish regular product quality metrics to satisfy Monitoring/Analysis of Quality Data requirements, including complaint rate reporting.
• Establish documented 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.
• As a backup, lead CAPA owners in effective planning around Corrective actions and Verifications of Effectiveness.
• Conduct internal audits.
• 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.

Knowledge/Educational Requirements
• Bachelor's degree in engineering discipline, plus 5 years of experience in a product quality role in a regulated environment. Opto-electro-mechanical assemblies and knowledge of lasers are a plus.
• 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 QMS
• Highly skilled 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)
• Knowledge of 3D modeling/drawings (SolidWorks) is a plus
• Engineering or Technical Degree
• Ability to work in collaboration with cross-functional teams.
• Capability to plan and organize own workload based on organization needs.
• Experience with CAPA process
• Some experience conducting Internal Audits
• 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 procedure
• Strong written/verbal communication skills, including presenting to senior management

Salary Range: $100-110k

This job description is not all inclusive and is intended to capture a majority of the job functions. Special projects and other tasks may be required by management.