Supplier Quality Engineer

3 weeks ago

Indianapolis, United States Sonablate Corp. Full time

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 the Sonablate Corp. 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.
  • Support Design for Manufacture and Assembly activities between the company and the 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 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 or equivalent work experience.
  • Minimum of 5 years of related Quality Assurance experience in a regulated manufacturing environment, preferably for medical devices.
  • 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)

Sonablate provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws.

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