Principal Quality Assurance Engineer

About this role

MicroAire Surgical Instruments LLC

As a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway— you’ll be doing things that matter, leading at every level, and winning a better way. We’re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best.

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.

+ Essential Duties and 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.

+ Education and Experience • 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. • Lean-Six-Sigma experience preferred.

+ Competencies Competency Skills Behaviors Quality Systems & Regulatory Compliance-

Demonstrates deep expertise in medical device quality systems, regulations, standards, and compliance requirements to ensure products and processes consistently meet regulatory and quality expectations. • FDA QSR/21 CFR 820 knowledge • ISO 13485 and ISO 14971 expertise • CAPA management • Internal auditing • Regulatory compliance assessments • Quality metrics analysis • Ensures compliance requirements are integrated into daily operations • Identifies and mitigates compliance risks proactively • Maintains thorough and accurate documentation • Serves as a trusted quality and regulatory resource across the organization Technical Problem Solving & Risk Management- Applies advanced engineering principles, statistical methods, and risk-based thinking to investigate issues, identify root causes, and implement sustainable solutions. • Root cause analysis • Failure investigation • Statistical analysis • Design of Experiments (DOE) • Risk assessment and mitigation • Data interpretation • Makes fact-based decisions using data and evidence • Identifies potential quality and product risks before they escalate • Develops effective corrective and preventive actions • Continuously seeks opportunities to improve product reliability and process performance Validation & Design Assurance- Ensures products, equipment, software, and manufacturing processes are appropriately verified and validated to meet intended use requirements and quality standards . • IQ/OQ/PQ development and execution • Process validation • Equipment qualification • Test method validation • Design controls • Verification and validation planning • Develops robust validation strategies and protocols • Evaluates process capability and qualification status effectively • Anticipates validation impacts resulting from design or process changes • Ensures objective evidence supports product and process acceptance Cross-Functional Leadership & Influence-

Leads quality initiatives and influences decisions across engineering, operations, supply chain, regulatory, and commercial teams without direct authority. • Project leadership • Facilitation skills • Conflict resolution • Stakeholder management • Supplier collaboration • Communication and presentation skills • Builds alignment

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