Quality Manager

Location: Irvine, California
Date Posted: 12-19-2018
NN, Inc. has an exciting opportunity for an experienced Quality Manager to join our team at our Irvine, CA facility!  This position is an integral part of the Plant Leadership Team and reports directly to the VP of Quality and Regulatory Affairs.  This is an exciting time of growth and change for the Power Solutions Group, and we are looking for a self-motivated team player who is driven by a passion to make a significant impact on our business operations and enhance value for our customers and stakeholders. 
 
WHO YOU ARE:
  • You are a champion of quality and compliance culture who leverages data to prioritize actions, drive continuous improvement and close the gap on “best in class” processes.
  • You have expert capabilities in the definition, application, and utilization of statistical process control techniques and methodologies.  
  • You have demonstrated leadership capabilities and the ability to facilitate the work activities of others
  • You work well both autonomously and collaboratively in a fast-paced, time-sensitive, and constantly changing environment. 
  • You have excellent interpersonal skills, with the ability to take initiative and build strong, productive relationships with internal and external stakeholders.
 
ESSENTIAL DUTIES:
  • Builds, manages, and sustains a team of technical quality associates assigned to product development and in-process quality.
  • Develops relevant training programs, instructs the work force in the use of appropriate quality and process tools, and provides benchmark data for relative comparison of quality performance.
  • Supports the development and implementation of a quality system that meets the ISO and FDA 820/GMP requirements and maintains ISO 13485 certification. 
  • Prepares for and represents the company with customer and regulatory representatives who conduct external audits of the corporate quality system.    
  • Drives continuous improvement activity through the collection and analysis of data and develops corrective actions that reduce waste and support key company objectives.
  • Works to integrate quality objectives into manufacturing processes driving defect identification to the earliest point possible. 
  • Supervises quality engineers and inspection processes using statistical sampling techniques and precision measuring instruments to validate conformance to customer requirements. 
  • Verify that all production procedures have been followed and the records maintained correctly per FDA and customer guidelines.  
  • Responsible for meeting customer requirements associated with the production of Medical Devices beginning with receipt of an order, specifying raw material, and processing to the shipment and documentation of finished goods.
  • Directs six sigma and lean manufacturing improvement projects. 
  • Provides budget inputs and tracks actual costs taking actions to comply with budgetary and strategic objectives. 
  • Reviews customer performance metrics and implements appropriate corrective action. 
  • Maintains and oversees all validated processes per customer directed process change guidelines. 
  • Monitors manufacturing processes and generates documentation in support of required customer approvals for process change.
  • Oversees the purchase of monitoring and measurement devices and coordinates their control and calibration through established corporate systems.
  • Oversees new order acceptance and processing through established company procedure and develops product specific Inspection and Control Plans based on customer blueprints and inspection criteria.
  • Leads project implementations related to Process Flow, Quality Systems, and Statistical process controls.
EDUCATION and/or EXPERIENCE:
Required:
  • Bachelor’s Degree
  • Minimum of 7 years of Quality Management or Quality Engineering experience
  • Expert proficiency in Microsoft Office Suite
Preferred:
  • Bachelor’s Degree in Business, Engineering, Quality Management or related technical or scientific field
  • Quality Management or Quality Engineering experience in the medical device industry or related field
  • ASQ Certification
 
JOIN US!

NN, Inc., a diversified industrial company, combines advanced engineering and production capabilities with in-depth materials science expertise to design and manufacture high-precision components and assemblies for a variety of markets globally.  NN has 36 facilities in North America, Western Europe, Eastern Europe, South America and China.
 
NN, Inc. provides a comprehensive benefits package, including:  
  • Medical and dental insurance
  • Employer-paid short-term disability and life insurance
  • Voluntary vision insurance and other ancillary plans
  • 401(k) plan with employer match
  • Paid vacation and holidays
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