Principal Quality Assurance Engineer

Marmon Holdings, Inc.•Charlottesville, VA

1d•$112,000 - $136,000•Hybrid

About The Position

The Principal Quality Assurance Engineer is a lead member of the Quality Assurance team. This individual is a technical expert and provides technical leadership for quality activities associated with the development of new medical devices and the continued support of current medical devices. The Principal Quality Assurance Engineer leads the overall activities including CAPAs, customer complaints, MRB/NCMRs, supplier quality, validations (equipment, process, test methods and software), design controls, process improvement, risk management, and internal audits. Also weighs in needed department resources as well as resource utilization. This individual will work with internal customers, external customers, and suppliers as the technical voice that will derive quality requirements. Requires comprehensive mechanical and technical problem-solving skills. The Principal QAE is responsible for mentoring QAEs, taking the lead on QAE projects, and will serve as a subject matter expert for QAE operations.

Requirements

Bachelor's degree in related field (engineering degree preferred)
At least 8 years of Quality Assurance manufacturing (mechanical and electrical) experience in the medical device industry.
American Society for Quality, Certified Quality Engineer (CQE) or equivalent required.
FDA QSR/21 CFR 820 knowledge
ISO 13485 and ISO 14971 expertise
CAPA management
Internal auditing
Regulatory compliance assessments
Quality metrics analysis
Root cause analysis
Failure investigation
Statistical analysis
Design of Experiments (DOE)
Risk assessment and mitigation
Data interpretation
IQ/OQ/PQ development and execution
Process validation
Equipment qualification
Test method validation
Design controls
Verification and validation planning
Project leadership
Facilitation skills
Conflict resolution
Stakeholder management
Supplier collaboration
Communication and presentation skills
Mentoring and coaching
Technical training
Knowledge transfer
Performance guidance
Continuous improvement methodologies
Subject matter expertise

Nice To Haves

Lean-Six-Sigma experience preferred.
ASQ Certifications preferred.

Responsibilities

Supports New Product Development/Design Control, performing quality engineering activities such as design inputs, design outputs, design verification, design validation, design transfer, and risk analysis/ management.
Ensures compliance to specifications and regulatory requirements and identifies opportunities to improve product and process quality.
Assists with the compliance of national and international standards and regulations.
Conducts analysis including design of experiments, as needed.
Generates qualification verification, and/or validation plans, protocols, and reports for new or updated manufacturing processes and equipment (IQ/OQ/PQ).
Understands the integration of component, design and process to ensure adequate process capability.
Drives the use of statistical analysis tools to understand process capability.
Reviews product and process changes and assesses impact on product reliability and qualification/validation status.
Assists in changing implementation.
Leads and participates in quality metrics reviews; identifying weaknesses and risks associated with MicroAire products and tracking the mitigation of those issues throughout the corrective action process.
Facilitates and aids cross-functional teams in performing complaint investigations and CAPA activities.
Dispositions any materials/components that are rejected for non-conformance with effective corrective actions.
Coordinates and consults with suppliers and supply chain to improve quality, cost and delivery from suppliers.
Works with incoming inspection to ensure adequate and robust quality inspections.
Performs gauge R&R, capability analysis, etc as required.
Available to provide support for outside sales force and customers to resolve product technical questions and instrument performance concerns, as needed.