Careers With Sonablate
SUPPLIER QUALITY ENGINEER
The Supplier Quality Engineer will be charged with establishing and maintaining strong supplier relationships to improve the performance of the company. The purpose of the role is to assist engineering to select suppliers and manage suppliers of parts and services to produce a best-in-class medical device. Establish and support a work environment of continuous improvement that supports SonaCare Medical’s Quality Policy, Quality System, appropriate regulations, and customer requirements. Responsible for performing regular supplier audits to ensure compliance with regulatory standards, as well as actively participating in strategic development based on quality control plans.
Duties and Responsibilities
- Carry out supplier validation audits, with supplier support and supplier advanced product quality planning (APQP)
- Assist Engineering in the supplier approval process by assessing manufacturing/technology capabilities
- Support new product launches to ensure that supplier quality meets the required standards
- Facilitate root cause analysis and corrective actions of supplier quality issues
- Perform on-site supplier visits for root cause analysis and verification of correction action of supplier quality issues
- Work with the supplier directly, creating correction action plans to address process failures
- Managing and developing suppliers, ensuring optimized levels of quality, cost, and delivery performance driving continuous improvement to maximize business performance.
- Perform quality audits of suppliers to ascertain their material and process controls. Work with suppliers to adequately address any audit findings.
- Work closely with Materials and Engineering to establish the Supply Chain structure to meet the requirements of the full product lifecycle of SonaCare Medical products.
- Support Design for Manufacture and Assembly activities between SonaCare Medical and suppliers.
- Manage quality issues in conjunction with key stakeholders, resolving day-to-day problems, ensuring effective containment and problem resolution for all non-conformances.
- Effectively document and communicate findings regarding improving the quality system and regulatory compliance.
- Oversee the first article inspection and work with suppliers to resolve failures due to raw materials or manufacturing processes
- Work with existing and new suppliers to put in place supplier quality agreements/contracts and Raw Material Specification agreements
- Generate and maintain quality system documentation.
- Work independently or with teams to complete investigations and lead quality improvement efforts.
- Benchmarking for best practices and incorporating them into existing systems.
- Assure regulatory compliance to meet the requirements of established certified standards, and customer requirements.
- Handle various projects and responsibilities simultaneously and successfully meet deadlines.
- Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
- Work with other groups or individuals to resolve issues.
- All other duties, as assigned.
- B.S. in a technical field from an accredited four-year college or university or equivalent work experience.
- Minimum of 5 years of related Quality Assurance experience in a medical device manufacturing environment.
- Current ASQ Certification desired.
- Six Sigma Green or Black belt certification desired.
- Strong knowledge of medical device quality system requirements.
- Working knowledge of data analysis techniques, Gage R&R, ANOVA, probability, DOE, SPC, and process capability.
- Excellent written and oral communication skills.
- Ability to work effectively with diverse groups of individuals.
- Strong knowledge of Advanced Product Quality Planning (APQP), Production Part Approval Process (PPAP), Failure Mode and Effect Analysis (FMEA)
Welcome to an established company, with a proven product, and a start-up feel. Sonablate Corp. was created following an acquisition of SonaCare Medical, LLC in 2021. We have designed, developed, manufactured, sold, and serviced the Sonablate HIFU ablation device for over two decades, receiving 510K de novo clearance with the FDA in 2015. The Sonablate device is cleared in more than 50 countries, including a CE Marking in the European Union and approval from the National Medical Products Administration in China.
Sonablate Corp. has two offices: one in Charlotte, NC and the other in Indianapolis, IN as well as remote employees spread out across the country. We stay focused by having monthly town hall meetings, tracking our progress toward annual goals, and passing all new projects through a rigorous vetting by our prioritization committee. We strive for transparency and clear communication throughout the company and look for candidates that want to dive in, effect change, and challenge us to become the best version of ourselves.
Our employees enjoy competitive salaries, bonus plans, and an employee stock option plan. Additionally, the company pays for 90% of the employee’s healthcare benefits, which are effective the first of the month following your first day on the job. We offer flexible working schedules for our hourly employees and a work-from-home policy for our salaried ones. We believe in giving our employees autonomy, mastery, and purpose and enjoy low turnover due to that philosophy.
Equal Opportunity Employer