Sr. Quality Assurance Engineer

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 Senior Quality Engineer will lead and participate in projects and activities associated with MicroAire’s quality system. Partner with cross-functional teams to continuously improve the Quality Management System (QMS) and its execution. Apply risk-based criteria to prioritize actions related to CAPA and post-marketing quality systems. Is responsible for multiple projects in order to ensure compliance with the company's quality systems and standards while enabling speed to market and attainment of company goals.

Leads Quality Engineering activities for the development of new medical devices. Serves on New Product Development Projects as a team member by providing quality engineering expertise including design verification, design validation, risk analysis, risk management reports, equipment installation qualification, process operational qualification, process performance qualification, packaging validation, sterilization validation and supplier quality.

+ Essential Duties and Responsibilities

·         Works with R&D and Manufacturing Engineers to support implementation of new products by developing quality and testing plans.  Supports the new product development process as a team member.  Answers any questions or concerns with device quality / reliability within the new product development team.

·         Participates in establishing and reviewing specifications/requirements for components, products and processes as part of new product development.  Provides feedback on manufacturing-related documentation for regulatory submissions and product release.

·         Participates in teams responsible for the procurement and installation, operational and performance qualification (IQ/OQ/PQ) of manufacturing equipment/processes.

·         Develops Quality Plans for quality systems that adhere to the QMS.

·         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.

·         Works with Suppliers to maintain high quality levels of incoming production materials.  Supports Supplier Quality by providing reliability input in the evaluation of discrepant material and in the qualification of new material to assure that device reliability requirements are met.  Participates in quality audits of suppliers.

·         Partners with cross-functional departments as required, mentoring and aiding teams in performing complaint investigations and CAPA activities.

·         Partners with suppliers and supply chain as required 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.

·         Utilizes standard statistical analysis and problem-solving techniques as necessary to determine product acceptance limits, establish process parameters, resolve quality problems, etc.

·         Supports quality system maintenance by identifying and correcting deficiencies in procedures and practices.

·         Leads and supports CAPA teams in the analysis and resolution of product quality issues.

·         Leads and implements QMS software solutions aimed at continuously improving the QMS.

·         Performs other job-related duties and activities as assigned.

+ Education and Experience

Education: Bachelor's degree in engineering or science discipline

Experience:

• ·         Six years of Quality or Manufacturing Engineering experience required, supplier quality engineer experience preferred
• ·         Medical device experience is highly desirable; regulated industry experience required
• ·         Fabrication, machining, and assembly knowledge and experience of mechanical and electrical assemblies are highly desirable

·         Lean-Six-Sigma experience preferred.

·         American Society for Quality, Certified Quality Engineer (CQE) preferred.

+ Competencies

Competency

Skills

Behaviors

Quality Systems & Regulatory Compliance-

Demonstrates deep knowledge of Quality Management Systems (QMS), regulatory requirements, and quality engineering principles to ensure products, processes, and systems consistently meet customer, company, and regulatory expectations.

• QMS management
• FDA, ISO 13485, and regulatory compliance
• CAPA systems
• Internal and external auditing
• Documentation and change control
• Design controls
• Ensures compliance requirements are integrated into daily activities.
• Proactively identifies and addresses quality system gaps.
• Maintains accurate and audit-ready documentation.
• Demonstrates strong attention to detail and regulatory discipline.

Risk Management & Problem Solving-

Uses data, risk-based thinking, and structured problem-solving methodologies to identify, assess, and mitigate product, process, and system risks while driving sustainable corrective actions.

• Risk analysis (FMEA, Risk Management Reports)
• Root cause analysis
• Statistical analysis
• CAPA leadership
• Data interpretation
• Corrective and preventive actions
• Prioritizes actions based on risk and business impact.
• Identifies root causes rather than treating symptoms.
• Uses data to make objective decisions.
• Drives timely resolution of quality issues and prevents recurrence

Technical Quality Engineering Expertise-

Applies engineering knowledge and quality methodologies throughout product development and manufacturing to ensure products are safe, effective, reliable, and manufacturable.

• Validation protocols (IQ/OQ/PQ)
• Design verification and validation
• Process qualification
• Supplier quality engineering
• Reliability engineering
• Test method development
• Provides technical leadership during product and process development.
• Anticipates quality challenges before they become issues.
• Balances compliance, quality, and speed-to-market objectives.
• Supports robust and scalable manufacturing solutions.

Cross-Functional Leadership & Influence-

Builds strong partnerships across departments and effectively influences stakeholders to achieve quality objectives, improve processes, and support business goals.

• Team facilitation
• Stakeholder management
• Conflict resolution
• Technical communication
• Supplier engagement
• Mentoring and coaching
• Establishes credibility with engineering, operations, regulatory, and supplier partners.
• Communicates complex quality concepts in a practical manner.
• Encourages participation and accountability across teams.
• Mentors others in quality tools and best practices.

• Continuous Improvement & Operational Excellence-
• Identifies opportunities to improve quality, efficiency, and effectiveness through process optimization, data analysis, and continuous improvement initiatives
• • Lean Six Sigma methodologies
• • Process improvement
• • Quality metrics analysis
• • Capability analysis

• Gauge R&R
• QMS software implementation
• Challenges ineffective processes and drives meaningful improvement.
• Uses metrics to identify trends and measure effectiveness.
• Implements sustainable solutions that improve quality and efficiency.
• Demonstrates a mindset of learning, innovation, and continuous improvement.

+ Work Environment, Physical Demands and Protective Equipment

Works in an office environment.  Periodic work in various manufacturing and culture environments.

Follows protective equipment procedures for each department and at outside suppliers.

Minimal physical demands, primary work in an office environment.

All required training for this role is documented in the individual training matrix within the MicroAire Training Management System and must be completed accordingly.

+ Schedule, Travel Responsibility, Special Conditions or Requirements

Provides training and acts as a mentor in area of expertise.  May provide leadership of focused teams.  May supervise supplier quality engineers or buyer/planners in projects.

Confidentiality:  Has read-only access to the engineering CAD database through the Network security system. Is limited to read-only access.  Also has knowledge of new products and will be required to maintain confidentiality.

Mental Application:  Errors made at this level could have a moderate to severe impact on the company due to the fact that this individual will be reviewing and approving work performed for specific products and/or projects.

Up to 10% travel required, including international.

Pay Range: $87,000- $105,005

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law .

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to careers@marmon.com, and please be sure to include the title and the location of the position for which you are applying.