Starkey Laboratories, Inc. Eden Prairie , MN 55344
Posted 4 days ago
Starkey is adding a Supplier Quality Engineer II to it's Quality team in Operations at it's global headquarters in Eden Prairie, MN. Ideal candidates will have several years of experience with contract manufacturing, working with processes and willing to learn. This position is responsible for the management of suppliers pertaining to hearing aid components and/or finished medical devices. The position will provide Quality Assurance, technical and compliance expertise for conducting supplier audits, qualifying new suppliers, monitoring the performance of current suppliers, and driving quality improvements. This position will include support of supplier corrective actions, nonconformance investigations and assessing the capabilities of new suppliers for product development projects.
Starkey is a world leader in the manufacturing and distribution of advanced hearing technologies. We are in the business of connecting people and changing lives. Our teams come to work each day focused on ensuring people everywhere have the products and services they need to hear better and live better. Founded in 1967 by Bill Austin, Starkey is known for our cutting-edge hearing health innovations, industry-leading research and development, and not being afraid to push the edge of what's possible. We are headquartered in Eden Prairie, Minnesota, have over 5,000 employees in 29 facilities across the globe, and conduct business in more than 100 markets worldwide.
Watch this video to see more of what sets Starkey apart.
https://youtu.be/9cUYwTlCepg?si=wkovx8_R_iINfrc6
JOB RESPONSIBILITIES/RESULTS
Manage suppliers of Starkey's purchased components
Drive quality improvement efforts with suppliers
Perform assessments of technical and quality capability of new suppliers
Assess current and potential suppliers and perform audits as required
Drive continuous improvement projects within the supply chain
Provide guidance and review of supplier corrective actions and nonconformance investigations
Ensure that Suppliers execute to Starkey's expectations
Ensure mutual understanding of the specifications and requirements
Work with supplier and utilize industry standard quality tools to ensure production capabilities and risk mitigation
Assist the sourcing organization in supply risk mitigation efforts
Assess capabilities of new suppliers
Assess potential suppliers quality systems and perform audits as required
Provide input to and utilize the supplier scorecard to identify improvement areas
Analyze supplier capabilities
Support supplier management team initiatives and strategies
Participate in Supplier risk assessment
Participate in supplier scouting activities
Participate in commodity team efforts driving improvement in Quality, Total Cost, Velocity, Risk Management and Innovation
Monitor and maintain QA activities.
Write incoming inspection test procedures
Disposition nonconforming material
Draft and release part qualification report
JOB REQUIREMENTS
Minimum Education, Certification and Experience Requirements
Education
4-year Bachelor's degree in Industrial, Manufacturing, Electrical or Mechanical Engineering
Experience
Minimum 3 years of experience in a manufacturing or quality engineering preferably including supplier management.
Knowledge / Technical Requirements
Understanding of ISO 9001 required; Medical device quality systems standards and regulations (ISO 13485, 21 CFR Part 820) desired
Working knowledge of APQP and PPAP desired
Understanding of the audit process including planning, execution, reporting and follow-up
Ability to read print/specifications and be able to communicate these needs to other entities
ASQ Six Sigma Green Belt desired with ability to lead and execute six sigma projects
Competencies, Skills & Abilities
Excellent analytical and problem solving skills required
Excellent communication and people skills required
WORK CONTEXT
Working Conditions
Equipment Operation
#LI-KS1
Starkey Laboratories, Inc.