Quality Assurance Engineer MicroAire Surgical Instruments LLC is part of the global industrial organization Marmon Holdings—backed by Berkshire Hathaway—where 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 diverse learning and working opportunities, and fostering a culture where everyone's empowered to be their best. Under broad supervision, conducts internal quality controls to ensure established quality procedures and norms are followed. Conducts non-routine quality analysis and tests/inspections of a quality control program, resolving most questions and problems and recommends necessary quality procedure changes. Monitors and records inconsistencies with quality procedures and norms. Records and analyzes customer claims and prepares reports on rejected or defective products. May assist in the development of new methods and procedures. Role typically requires between 3 and 5 years of experience. MicroAire is seeking talented Quality Engineers at multiple experience levels. Candidates may be considered for either a Quality Assurance Engineer or Senior Quality Assurance Engineer position based on qualifications, experience, and demonstrated capabilities. The Quality Assurance Engineer supports and leads quality engineering activities associated with new product development, sustaining engineering, supplier quality, and Quality Management System (QMS) initiatives within a regulated medical device environment. This role partners with cross-functional teams to ensure products, processes, and systems meet quality, regulatory, and customer requirements while supporting innovation, operational excellence, and continuous improvement. Depending on experience and qualifications, the successful candidate may be hired at the Quality Assurance Engineer or Senior Quality Assurance Engineer level.
Essential Duties and Responsibilities:
Support and/or lead quality engineering activities related to new product development, design control, and sustaining engineering programs.
Participate in design verification, design validation, risk management, process validation, packaging validation, sterilization validation, and design transfer activities.
Develop, execute, and review validation and qualification protocols and reports, including IQ/OQ/PQ activities.
Ensure compliance with applicable FDA regulations, ISO standards, company procedures, and other regulatory requirements.
Support and/or lead CAPA, complaint investigations, nonconformance investigations, root cause analysis, and corrective action activities.
Evaluate product and process changes and assess impact on product quality, validation status, and regulatory compliance.
Collaborate with R&D, Manufacturing, Regulatory Affairs, Supply Chain, and Operations teams to drive quality objectives and support product launches.
Support supplier quality activities including supplier qualification, audits, incoming quality issues, and material discrepancy resolution.
Utilize statistical analysis and data-driven decision-making to evaluate process capability, quality trends, and product performance.
Participate in quality metrics reviews and continuous improvement initiatives to improve QMS effectiveness and operational performance.
Support internal and external audits and assist in maintaining an inspection-ready quality system.
Assist with or lead implementation of quality system improvements, software tools, and process optimization projects.
Provide technical quality guidance to cross-functional teams and, at the senior level, mentor less experienced team members.
Perform other duties as assigned.
Education and Experience:
RequiredBachelor's degree in Engineering, Science, or a related technical discipline.
Quality Assurance Engineer0 to 3 years of quality, manufacturing, or engineering experience.
Experience in a regulated manufacturing environment preferred.
Knowledge of FDA, ISO 13485, CAPA, validation, and quality systems preferred.
Senior Quality Assurance Engineer 6+ years of quality or manufacturing engineering experience.
Experience in medical devices or another highly regulated industry required.
Demonstrated experience leading CAPAs, risk management activities, validation programs, supplier quality initiatives, and quality improvement projects.
Prior experience mentoring or providing technical leadership preferred.
Preferred Qualifications:
Medical device industry experience.
Supplier quality experience.
ASQ Certified Quality Engineer (CQE) or other ASQ certification.
Lean Six Sigma certification or experience.
Experience with statistical analysis, process capability studies, and quality improvement methodologies.
Core Competencies:- Quality Systems & Regulatory Compliance
- Applies quality engineering principles, Quality Management System requirements, and regulatory standards to ensure compliant products, processes, and documentation.
- SkillsFDA and ISO 13485 compliance
- Quality systemsCAPA management
- Change control
- Audit support
- Design controls
- BehaviorsMaintains compliance-focused decision making.
- Produces accurate, audit-ready documentation.
- Identifies and addresses quality system gaps.
- Demonstrates strong attention to detail.
Risk Management & Problem Solving:- Uses data, risk-based thinking, and structured methodologies to identify issues, evaluate risks, and implement sustainable solutions.
- SkillsRoot cause analysis
- Statistical analysis
- Risk managementFMEACAPA investigations
- Data interpretation
- BehaviorsMakes objective decisions using data.
- Identifies root causes and preventive actions.
- Prioritizes issues based on risk and impact.
- Drives timely issue resolution.
Technical Quality Engineering:
Applies quality engineering methodologies throughout product development and manufacturing to ensure safe, effective, and reliable products. Skills Validation (IQ/OQ/PQ) Design verification and validation Process qualification Supplier quality Product testing Reliability engineering BehaviorsEnsures objective evidence supports quality decisions. Anticipates quality risks. Supports scalable manufacturing solutions. Balances compliance, quality, and business objectives.
Collaboration & Influence:
Builds productive relationships across functions and communicates quality requirements effectively. Skills Technical communication Team facilitation Stakeholder management Supplier engagement DocumentationMentoring and coaching BehaviorsBuilds credibility across departments. Communicates complex concepts clearly. Encourages accountability and teamwork. Shares knowledge and best practices.
Continuous Improvement & Operational Excellence:- Drives improvements in quality, efficiency, and effectiveness through analysis, innovation, and process optimization.
- SkillsLean Six Sigma
- Quality metrics
- Process improvement
- Capability analysisQMS software
- Project management
- BehaviorsIdentifies opportunities for improvement.
- Uses metrics to drive decisions.
- Implements sustainable solutions.
- Demonstrates ownership and initiative.
Work Environment:
Primarily office-based with periodic work in manufacturing environments.
Must follow all safety and PPE requirements.
Ability to traverse manufacturing areas and occasionally lift up to 25 pounds.
Must complete all required quality system and training requirements.
