Quality Assurance Engineer

About the Role

The Quality Assurance Engineer is an entry-level engineering role responsible for supporting quality activities associated with both new product development and sustaining engineering initiatives. The position supports the development, validation, maintenance, and continuous improvement of medical devices and manufacturing processes within a regulated environment. Working under the guidance of senior quality professionals, the role participates in CAPAs, complaints investigations, supplier quality activities, validation projects, risk management, design control activities, audits, and continual improvement efforts to ensure compliance with quality system and regulatory requirements.

Key Responsibilities

• Ensures compliance to specifications and regulatory requirements and identifies opportunities to improve product and process quality. Assists with the compliance of domestic and international standards and regulations.
• Learns and applies QMS requirements and external standards to all related activities.
• Reviews product and process changes and assesses impact on product conformance, reliability, and qualification/validation status. Assists in change implementation including generation of change orders.
• Dispositions any materials/components that are rejected for non-conformance with effective corrective actions to prevent recurrence.
• Generates qualification verification, and/or validation plans, protocols, and reports for new or updated manufacturing processes and equipment (IQ/OQ/PQ).
• Drives the use of statistical analysis tools to understand process capability. Conducts analysis including design of experiments, as needed.
• Supports sterilization validations and product testing to maintain product sterility.
• Leads and/or participates in corrective/preventive action teams (CAPAs, NCMRs, Complaints) in resolving production and customer issues.
• 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.
• Works with Suppliers and Supply Chain to maintain high quality levels of incoming production materials. Supports Supplier Quality by providing input in the evaluation of discrepant material and in the qualification of new material to assure that device reliability requirements are met.
• Provides support to outside sales force and customers to resolve product technical questions and instrument performance concerns, as needed.
• Performs other duties as assigned.

Requirements & Tech Stack

• Quality Fundamentals & Regulatory Compliance
• Skills: QMS procedures and documentation, FDA and ISO awareness, CAPA participation, Document control, Change management support, Audit preparation
• Behaviors: Follows established procedures consistently, maintains accurate and complete documentation, learns and applies quality and regulatory requirements appropriately, escalates compliance concerns in a timely manner, demonstrates attention to detail and commitment to quality.
• Analytical Thinking & Problem Solving
• Skills: Root cause analysis, Data interpretation, Statistical analysis basics, Risk assessment support, CAPA investigations, Problem-solving tools
• Behaviors: Uses facts and data to support decisions, investigates issues thoroughly before drawing conclusions, identifies trends and potential risks, supports implementation of corrective actions, demonstrates curiosity and a continuous learning mindset.
• Quality Engineering & Validation Support
• Skills: IQ/OQ/PQ execution, Design controls support, Verification and validation activities, Supplier quality support, Product testing, Risk management participation
• Behaviors: Executes quality engineering activities accurately and consistently, supports validation and qualification activities effectively, ensures objective evidence supports quality decisions, learns how product, process, and design changes impact overall quality, demonstrates growing technical proficiency.
• Collaboration & Communication
• Skills: Teamwork, Written communication, Technical documentation, Stakeholder communication, Supplier interaction, Active listening
• Behaviors: Works effectively with engineering, manufacturing, supply chain, and quality teams, seeks input and feedback from others, communicates issues and recommendations clearly, shares information proactively and professionally, supports a positive team environment.
• Continuous Improvement & Initiative
• Skills: Process improvement, Lean principles, Corrective action support, Organizational skills, Project coordination, Time management
• Behaviors: Takes ownership of assigned work and follows through on commitments, identifies opportunities for improvement and efficiency, supports implementation of process improvements, demonstrates initiative in solving problems and learning new skills, embraces feedback and seeks opportunities for growth.
• Initiating Action
• Skills: Ownership, Accountability, Project execution, Follow-through
• Behaviors: Takes prompt action on issues, follows through on commitments, proactively identifies and addresses potential problems.

Qualifications

• Bachelor's degree in a related field (engineering degree preferred).
• No experience required. 0-2 years Quality Assurance manufacturing experience in a medical device industry or similar highly regulated manufacturing environment preferred.
• ASQ Certifications preferred.
• Must maintain compliance with all quality system, regulatory, safety, and training requirements.
• Expected to work effectively in a highly regulated medical device manufacturing environment.

Work Environment & Physical Demands

• Works in an office environment.
• Periodic work in various manufacturing environments.
• Follows protective equipment procedures for each department.
• Prolonged periods sitting at a desk and working on a computer.
• Must be able to traverse the production facility.
• Must be able to lift up to 25 pounds at a time.

Schedule & Travel

• Full-time exempt position.
• Standard business hours with flexibility as business needs require.
• Occasional travel may be required for supplier visits, audits, training, or business support activities.