serp_jobs.breadcrumb.workplace_remote Quality assurance serp_jobs.h1.location_city

The Opportunity

This position works out of our Plano, TX location in the Neuromodulation Division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.

As a Supervisor Quality Assurance, main responsibility will include ensuring the quality standards and procedures are upheld in all site and operational processes. Role expectations will include leading a team in monitoring, evaluating, and improving operational efficiency and effectiveness while maintaining compliance with regulatory requirements and company standards.

What You’ll Work On

Quality Assurance Oversight : Oversee the implementation and maintenance of quality assurance processes and procedures throughout all site and operational activities.

Team Leadership : Lead a team of quality assurance specialists, providing guidance, training, and support to ensure their effectiveness in executing quality control measures. Sets standards and monitors staff performance, provide performance feedback, write and conduct performance evaluations for employees, and provide input for recommended merit increases and promotions. Proven experience in leading and motivating teams to achieve quality objectives and drive performance improvements. Adjusts communication style and medium (oral, written, or electronic) to meet the needs of the receiver (direct reports, peers, customers, managers); summarizes data and distills it down to relevant points to enhance understanding and uses appropriate level of language and detail for the receiver. Makes plans to accomplish assigned daily activities and simple projects and establishes priorities so as to handle competing demands. Optimizes use of available resources, estimates time and resources necessary to complete daily tasks or projects.

Process Improvement : Identify areas for process improvement to enhance efficiency, reduce errors, and optimize resource utilization. Commitment to ongoing learning, development, and implementation of best practices to drive continuous improvement within the team and for the site; champions specific projects. Lead teams to customer-oriented solutions that make business sense.

Quality Management and Monitoring : Develop and implement systems for monitoring the quality of products, services, and operational processes, including regular audits and inspections. Strong understanding of quality management principles, methodologies, and tools, such as Six Sigma, Lean, and Total Quality Management. Communicate department objectives and results. Exchanges information with employees, peers, and knows when to escalate to management.

Compliance Management : Ensure compliance with industry regulations, company policies, and quality standards, and implement corrective actions as needed. Identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc Identify risk areas within your group and develop strategies to mitigate as necessary

Mentorship and Coaching : Assist employees in the creation of development plans and work with employees to meet their development needs. Provide guidance, direction, training, resources, and time. Create an environment of trust and respect within the group while promoting productivity and morale. Listens to different points of view, taking ownership and responsibility for own actions.

Decision Making and Problem Solving : Bases decisions on the overall good, rather than on benefit to a particular functional area, serves as a champion for specific projects and initiatives. Adapts to and supports change in a timely, positive manner. Utilizes good judgment and makes timely decisions which consider the facts and data at hand; knows when to escalate to management. Strong problem-solving abilities to analyze complex issues, develop innovative solutions, and implement effective corrective actions.

Data Analysis and Documentation : Analyze quality data and performance metrics to identify trends, root causes of issues, and opportunities for improvement. Maintain accurate documentation of quality procedures, issues, and resolutions. Prepare regular reports on quality performance for management review. Gather and prepare trend information and recommend areas of focus. Assist in the development and execution of projects to improve processes, reduce costs, and maintain operations.

Cross-Functional Collaboration : Collaborate with other departments, such as production, engineering, planning, purchasing, and program management, to address quality-related issues and drive continuous improvement initiatives. Manages assigned projects and works cross functionally to identify changes and necessary resources. Identifies and communicates need for change. Contributes to the creation of the team's mission, objectives, and strategies, accepts team decisions and works toward their implementation with others.

Required Qualifications

Bachelor's Degree or an equivalent combination of education and work experience

Minimum 5 years of experience

Experience in the medical device industry or other regulated industry; previous experience in supervisory / leadership; Six Sigma training / certifications

Analytical Skills : Proficiency in data analysis and interpretation to identify patterns, trends, and opportunities for process optimization

Communication Skills : Excellent verbal and written communication skills to effectively convey quality requirements, findings, and recommendations to diverse stakeholders

Attention to Detail : Keen attention to detail to identify discrepancies, deviations, and areas for improvement in operational processes

Regulatory Knowledge : Familiarity with industry regulations and standards relevant to the organization's operations, such as ISO, FDA, or other regulatory bodies and standards affecting IVDs, IVDR, and biologics, etc.

Technical Proficiency : Comfortable using quality management software, data analysis tools, and other relevant technologies to support quality assurance efforts