Sr Manager Quality Manufacturing

at Starkey Laboratories, Inc. in Eden Prairie, Minnesota, United States

Job Description

Description

Starkey is hiring a Sr. Manager Quality Manufacturing at it's global headquarters in Eden Prairie, MN. Are you looking for an opportunity to be a key partner to global operations and quality? This position ensures the quality of the manufacturing processes and products and adherence to the Starkey QMS and global regulatory requirements. Lead quality control, assurance and QMS compliance by developing metrics/goals, creating and executing quality plans to meet improvement goals, and leading improvement projects across our global manufacturing, repair and refurb services Utilizing a data driven approach to establish improvement priorities and best practices, this hands-on position will work with the global locations to replicate and implement the best practices in all manufacturing locations. Key partner to Global operations and Global quality. Provide a high standard of product quality that conforms to global standards and regulatory requirements while ensuring a primary focus on patient safety and reliable product performance.
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
Assure customer requirements are met and product meets specification while improving cost of quality.
Evaluate and develop talent of the organization to utilize standard problem-solving methods and tools to reduce defects and improve process capabilities.
Conduct Quality/Six Sigma training and coach local teams to use the right mindset and tools to eliminate defects. - Quality planning and local execution to transform organization to quality prevention and assurance mindset.
Identify opportunities and lead or champion cross functional teams to reduce COPQ.
Assure linkage of Customer Requirements to Product Specifications, Component Critical Features and specifications, and Process Control plans.
Coordinate review and updates to Process FMEA's to assure risks have been identified and mitigated. Assure PFMEA's and control plans are implemented, and key processes are capable of meeting specifications.
Collect and analyze data and champion improvement activities to reduce customer complaints and improve internal processes and the quality of suppliers.
Collaborate as needed with Customer Quality, Sales, Marketing, Engineering, Sourcing, and Supply Chain to assure customer requirements are satisfied.
Monitor and report quality performance KPI's for the repair product and share with local/ regional management.
Assure compliance with all Global Quality System requirements and maintain ISO 13485 certification where required.
Organizational Improvement

o Implement new operational tools and methods to improve product quality and operational efficiency
o Driving awareness to issues and organizing teams to address where appropriate.
o Partner with the cross functional development teams to ensure the QMS is efficient and effective. Escalate non-conformances as identified
o Support and mentor cross functional teams to ensure sound, systematic problem-solving methodologies are utilized to identify, prioritize, communicate, and resolve quality issues through the product life cycle
Communication with Starkey Customers (Audiologist or Dispenser) and/or Starkey's Patients
Communication with external Regulatory Agencies (FDA, ISO, BSI, etc.)
Other duties/responsibilities as assigned
JOB REQUIREMENTS
Minimum Education, Certification and Experience Requirements
Education
o At least a 4-year college degree (M.S. preferred) in Engineering or equivalent required
o Certified Blackbelt or equivalent required
o Lean Expert or equivalent preferred
Knowledge / Technical Requirements
Knowledge of Good Manufacturing Practice.
Knowledge and understanding of Quality control and Quality assurance tools
Knowledge of ISO 13485 required

Experience
Minimum 10 years of quality assurance experience required
Experience with Operations and cross functional team leadership required. o Experience leading quality improvement projects and CAPA's
Competencies, Skills and Abilities
Excellent analytical and problem-solving skills required.
Excellent... For full info follow application link.

Starkey Hearing Technologies is an Equal Opportunity Employer Minority/Female/Vet/Disabled.