Sr Quality Engineer

About the role

The Senior Quality Engineer operates as the definitive quality authority across medical device development and manufacturing for the organization. This individual exercises expert judgment and independent evaluation to resolve complex quality issues that arise during the product lifecycle. They are responsible for devising innovative approaches to overcome persistent problems in design, process, and compliance. The role requires ownership of the entire quality system, from strategic planning to detailed execution and continuous improvement. This position provides technical guidance on intricate quality matters and requires supervisory approval for significant project plans. The engineer will communicate quality objectives throughout the organization and ensure their practical implementation in every operational function.

Key facts

What you'll do

• Orchestrate the development and qualification activities for both new and existing products, ensuring all deliverables meet regulatory and customer expectations.
• Direct and participate in cross-functional project teams, coordinating the quality efforts necessary to design, develop, and drive continuous improvement initiatives for medical devices.
• Execute engineering work of significant complexity, navigating conflicting design requirements, unsuitability of standard materials, and intricate coordination dependencies within quality frameworks.
• Design, implement, and validate methods and procedures specifically created for inspecting, testing, and evaluating the precision, accuracy, and performance of medical equipment.
• Develop and validate measurement systems and protocols, ensuring data integrity and compliance with industry standards for all quality-related activities.
• Monitor design control documentation rigorously to assure that new products fully meet established guidelines, while developing success metrics and maintaining currency with evolving regulatory standards.
• Provide proactive support to developmental projects in the quality assurance domain, contributing expertise from initial concept through commercial launch.
• Analyze detailed reports and returned product data to recommend and drive effective corrective and preventive action initiatives that eliminate root causes.
• Perform advanced statistical analysis to determine accountability for products or materials that fail to meet required standards, implementing data-driven solutions.
• Actively participate in NCR and CAPA board proceedings, representing the quality function and ensuring all non-conformances are addressed systematically.
• Assist in the delivery of QSR training programs, ensuring all personnel understand and comply with quality system requirements and regulatory mandates.
• Provide critical support during FDA inspections, FDB inspections, and notified body audits, managing documentation and responses with precision.
• Contribute to the development, review, and maintenance of standard operating procedures that govern quality operations and compliance.
• Prepare comprehensive documentation for inspection and testing procedures, ensuring protocols are clear, complete, and audit-ready.
• Execute all responsibilities mandated by the Quality System, while performing additional duties as assigned by management to support organizational goals.

Requirements

• Hold a Bachelor's degree in Engineering, a Life Science, or a related field with a minimum of 5 years of relevant professional experience, including demonstrable background in Quality Assurance and ISO standards, or possess an equivalent combination of education and experience typically found in a medical device or heavily regulated industry environment.
• Possess an Advanced degree such as a Master's or PhD, which is preferred and highly desirable for this senior-level position.
• Demonstrate extensive experience applying IEC 60601 standards within complex medical device environments, showing a proven track record of compliance and implementation.
• Show deep experience with Process Failure Mode and Effects Analysis (PFMEA), managing sustaining projects, commercial medical device manufacturing processes, Non-Conformance Reports (NCRs), Failure Investigations, and formal Change Control procedures.
• Have substantial experience in auditing practices, design review facilitation, sterilization validation methodologies, project management frameworks, and product development lifecycle management.
• Bring hands-on experience with Electronic devices and or Printed Circuit Board Assemblies (PCBAs), understanding the unique quality challenges they present.
• Have direct experience with Contract Manufactured Electromechanical Medical device products, including the associated quality systems and regulatory pathways.
• Exhibit a thorough understanding of relevant security, privacy, and compliance principles, adhering strictly to all applicable regulations, standards, and internal procedures without exception.

Nice to have

The source listing does not specify any items explicitly labeled as "Nice to have"; all listed qualifications and duties are considered core expectations for the role.

Practical notes

Business travel from 0% - 10%.

Potential exposure to blood-borne pathogens.

Requires some lifting and moving of up to 25 pounds.

Must be able to move between buildings and floors.

Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.

Must be able to read, prepare emails, and produce documents and spreadsheets.

Must be able to move within the office and access file cabinets or supplies, as needed.

Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.