Quality Assurance Specialist

Your Mission

As the Quality Systems Lead, you will play a key role in protecting the quality, safety, and reliability of the products we manufacture while strengthening the systems and processes that support them. You will serve as a Quality Management System (QMS) process owner and work across the organization to ensure our quality systems remain compliant, effective, and continuously improving. Through quality investigations, CAPA, risk management, audits, process validation, change review, and data-driven improvement, you will help identify issues before they become problems and drive sustainable solutions when improvements are needed. Working closely with Engineering, Manufacturing, Suppliers, and other functional teams, you will help ensure that quality is built into our products and processes, not simply inspected at the end.

What You’ll Do – Essential Duties and Responsibilities

Quality Management System & Compliance

• Serve as the Quality System process owner for designated QMS elements, ensuring ongoing compliance, effectiveness, and continuous improvement.
• Develop, maintain, and continuously improve the Quality Management System, policies, and procedures in accordance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements.
• Participate in and support internal, customer, regulatory, and certification audits of the Quality Management System.
• Support organizational compliance with applicable federal, state, local, and industry regulations, standards, and internal policies.
• Review and approve product, process, and quality system changes to ensure appropriate quality and regulatory requirements and risk considerations are addressed.

Investigations, CAPA & Risk Management

• Facilitate and conduct quality investigations, identify root causes, and drive effective corrective and preventive actions (CAPAs).
• Lead the investigation, documentation, and resolution of Quality Control Nonconformances (QCNs).
• Perform risk assessments and support Risk Management activities in accordance with ISO 14971 throughout the product lifecycle.
• Drive continuous improvement through defect prevention, stronger process controls, and sustainable corrective actions.

Product & Process Quality

• Assist in the development and maintenance of product quality plans and quality assurance strategies.
• Partner with Engineering, Manufacturing, and Suppliers to support the consistent delivery of conforming products and processes.
• Support process validation activities, including protocol review, execution support, and validation documentation.
• Support Quality Control operations and product quality activities as needed.

Quality Improvement & Cross-Functional Leadership

• Collaborate across functions to identify, evaluate, and resolve significant quality-related issues.
• Analyze and report quality system metrics and trends to support management review and informed decision-making.
• Identify, lead, and support quality improvement initiatives that enhance compliance, operational efficiency, and product quality.
• Promote a culture of quality, accountability, prevention, and continuous improvement throughout the organization.
• Promote compliance with applicable safety requirements, regulations, and workplace standards.
• Maintain and expand professional knowledge through ongoing education, training, and professional development.
• Perform other duties and responsibilities as assigned.

What You’ll Bring

Required Qualifications

• Prioritize safety and actively demonstrate safe practices in every task. Lead by example in maintaining a safe work environment and encourage your co-workers to do the same
• A passion for working in a fast-paced, safety-oriented, mission-driven manufacturing environment.
• Quality Systems Knowledge: Strong working knowledge of Quality Management Systems within a regulated manufacturing environment, including ISO 13485 and applicable FDA quality system requirements.
• Problem Solving & Root Cause Analysis: Demonstrated ability to investigate complex quality issues, identify root causes, evaluate risk, and develop effective and sustainable corrective actions.
• Risk-Based Thinking: Ability to apply risk management principles to products, processes, changes, and quality system activities.
• Analytical Skills: Ability to analyze quality data and trends, identify areas of concern or opportunity, and translate information into meaningful actions.
• Cross-Functional Collaboration: Ability to work effectively with Engineering, Manufacturing, Quality Control, Suppliers, and other functions to resolve issues and advance quality objectives.
• Leadership & Influence: Ability to lead quality initiatives and drive accountability and improvement across functions, including situations where direct reporting authority may not exist.
• Communication: Strong written and verbal communication skills with the ability to clearly document investigations, findings, risks, and recommendations and effectively communicate quality expectations.
• Organization & Attention to Detail: Ability to manage multiple quality system activities and priorities while maintaining accurate, complete, and compliant documentation.
• Continuous Improvement: Demonstrates a proactive approach to identifying opportunities to strengthen processes, prevent defects, improve efficiency, and enhance overall quality performance.
• Computer Skills: Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, Outlook, and Teams. Ability to effectively use electronic Quality Management Systems (eQMS), document control systems, ERP systems, and other business applications used to manage quality records and processes. Strong Excel skills with the ability to organize, analyze, and interpret quality data, metrics, and trends. Ability to learn and effectively utilize new quality, manufacturing, and business systems as needed.

Physical and Work Environment Requirements

• Demonstrate a consistent commitment to maintaining a safe work environment for yourself and others.
• Follow all company safety policies, procedures, and required personal protective equipment (PPE) practices.
• Ability to work in both professional office and manufacturing environments.
• Regular use of a computer and other standard office equipment.
• Ability to move throughout manufacturing, Quality Control, laboratory, warehouse, and other operational areas as needed to investigate quality issues, observe processes, and support quality activities.
• Ability to wear required personal protective equipment (PPE) when working in designated areas.
• Ability to occasionally lift and move materials weighing up to 25 pounds.
• Must be able to perform the essential functions of the position with or without reasonable accommodation.

Supervisory Responsibilities

Not applicable

Travel Requirements

Occasional travel may be required to support supplier activities, audits, training, business meetings, or other quality-related needs.