Supplier Quality Engineer

Indianapolis, IN

About SonaCare Medical:

SonaCare Medical is a world leader in minimally invasive focused ultrasound (HIFU) technologies. SonaCare Medical is committed to developing focused ultrasound related technologies that support precise and innovative procedures for the treatment of a range of medical conditions. SonaCare Medical, with its subsidiary Focus Surgery, Inc., designs and manufactures medical devices, including the following: Sonablate®, which has 510(K) clearance in the U.S. under a De Novo regulatory classification; Sonablate® 500, which has CE Marking and has obtained regulatory authorization in more than 49 countries outside the U.S.; Sonatherm® laparoscopic HIFU surgical ablation system, which has 510(K) clearance in the U.S., has CE Marking and has obtained regulatory authorization in more than 30 countries outside the U.S.

Summary:

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 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.

Qualifications/Specifications:

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)

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