Manager, Quality Engineering

The Manager, Quality Engineering will be responsible for ensuring Nalu's products meet the highest quality standards and comply with all relevant regulations and industry standards. The Manager plays a critical role in ensuring the safety, efficacy, and reliability of the company's products while developing the Quality Engineering team members and fostering a culture of compliance within the Company. This position is based in the office at our Carlsbad facility.

Responsibilities:

• Manages and leads a team of quality engineers and technicians, providing guidance, training, and support to ensure their professional development and performance

• Ensures quality assurance activities are carried out effectively

• Oversees testing and validation processes, as necessary, including protocol and report development, to ensure compliance with quality standards

• Monitors and analyzes quality metrics and performance indicators to identify trends, areas for improvement, and opportunities for process optimization

• Conducts or participates in risk management activities and implementing risk management strategies to identify and mitigate potential quality issues for new and existing products and processes

• Oversees the management of complaint investigations ensuring that they are investigated, analyzed, and resolved in a timely manner, as well as CAPAs to address root cause and prevent recurrence of quality issues

• Oversees the management of the sterilization program including validations, monitoring, and environmental controls

• Reviews Change Orders and assess quality impact of product and process changes

• Promotes a culture of continuous improvement within the department and the broader company

• Proactively drives activities to meet and/or exceed company objectives

• Establishes and maintains quality control procedures, including inspection/control plans, testing protocols, and documentation requirements

• Collaborates with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality considerations are integrated into new product development, and manufacturing processes

• Participates in internal and external audits to assess compliance with quality standards and regulatory requirements.

• Uses appropriate statistical tools such as collecting and summarizing data, drawing conclusions with confidence, determining sample sizes, applying Statistical Process Controls (SPC), identifying relationships between variables, and statistical decision making

• Collaborates with suppliers, contract manufacturers, and the internal supply chain team to ensure adherence to quality standards and specifications, while applying supplier management principles such as supplier selection, qualification, certification, and performance improvement, traveling to such partners when necessary

• Develops and validates test methods while applying metrology techniques such as calibration systems, traceability, measurement error, and control of standards and devices, conduct measurement system error studies such as Gage R&R

• Keeps up-to-date with industry trends, regulatory changes, and best practices in quality engineering for medical devices, and implementing necessary updates to the quality management system

• May act as project lead for functional and cross-functional projects, including generation of the project definition, plan, and requirements

• Performs other related duties and responsibilities as assigned

Requirements:

• Bachelor's degree in a scientific or related field

• Minimum of 7 years experience in quality engineering for medical devices

• Minimum of 4 years experience directly managing employees

• Strong understanding of quality management systems, regulatory requirements, and industry standards specific to medical devices, including a working knowledge of 21 CFR 820, ISO 13485:2016, and ISO 14971:2019

• Strong understanding of the product development process

• Experience with software-related medical device development

• Extensive experience with root cause analysis and statistical data analysis

• Establishes and fosters an environment of strong collaborative relationships with internal, cross-functional partners, suppliers, and service providers.

• Demonstrated ability to manage and prioritize assigned project tasks to deliver on-time, on-quality, and on-budget

• Oversees or participates in the development and execution of detailed validation test protocols •Experience with sterilization and packaging validation activities preferred

• Excellent leadership, communication, and problem-solving skills to effectively manage a team and drive continuous improvement in quality processes and outcomes

• Detail-oriented with strong organizational and project management skills

• Strong attention to detail and ability to work in a fast-paced environment

• Demonstrated ability to collaborate effectively with cross-functional team members

• CQE Certification preferred