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Quality Assurance Senior Manager

Charlotte, North Carolina
NN, Inc.'s Life Sciences Group has an exciting opportunity for a Quality Assurance Senior Manager to join our fast-growing team! This role will be based out of either our Corporate office in Charlotte, NC or our Bridgeport, CT facility and will report directly to the Group VP of Quality and Regulatory Affairs.

The ideal candidate will have to be okay with up to 60% overnight travel, have prior experience within the Aerospace/Defense or Medical Manufacturing industries, experience with ISO 13485 and exceptional compliance experience. Along with the following requirements:
  • Strong Medical Device
  • Hands on manufacturing quality experience
  • Proven leadership experience

SUMMARY:
Under the direction of the Group VP of Quality and Regulatory Affairs, the Quality Assurance Sr. Manager is responsible for operational compliance with NN Life Science’s QMS, FDA, and ISO 13485 requirements and to ensure that all products manufactured by the organization meet customer specifications, customer requirements and Medical Device requirements per FDA 21 CFR 820. This position is responsible for multiple domestic and international manufacturing and design sites and leading all quality operations functions. Will be responsible for working closely with site leadership teams in driving day to day operations and ensuring compliance to the site procedures and regulatory requirements and timely and effective management of Quality Management System and the Key Performance Indicators (KPI).
 
ESSENTIAL DUTIES AND KEY RESPONSIBILITIES:
  • Provides day-to-day leadership and management that mirrors the adopted mission and core values of the company
  • Management of NN Life Science’s daily Quality function supporting operations to include customer satisfaction, complaint management, new product introduction, product transfer, inspection, non-conformance, calibration, inspection methodology, device history records, training, statistical process control, risk management, and guidance on plant metrics
  • Develops client relationships to better understand requirements and to provide point of contact to improve customer satisfaction
  • Supervises the Quality Managers at selected facilities and associated internal quality functions
  • Responsible for responses and closure of customer non-conformances which includes solid, documented and compliant investigation and corrective actions
  • Drives process improvement and statistic process control to improve quality performance and to minimize reliance on inspection
  • Lead the selection and development of state of the art quality inspection methods and technology to ensure effective and efficient product verification applications
  • Lead and develop the Quality Assurance team which comprises: Quality Assurance, Quality Control, Quality Engineering and Supplier Quality
  • Ensure on-going compliance with FDA's QSR/GMP requirements and any other applicable regional and international regulations
  • Implements and enforces daily compliance of NN Life Sciences quality system that meets the FDA QSR regulations and is certified to ISO Standards. Accomplishes this in a manner that is complimentary to manufacturing operations
  • Prepares for and represents the company with customer and regulatory representatives conducting inspections/audits of NN Life Sciences systems and facilities
  • Leads Quality Systems Management Review of the QSR and provides resources supporting the Internal Audit function
  • Participates in the internal and external CAPA functions
  • Provides budget inputs and tracks actual costs taking actions to comply with budgetary and strategic objectives.Establish, track and report performance metrics as established

 EDUCATION and/or EXPERIENCE
Required:
  • Bachelor’s / Masters’ Degree preferably in a technical field of study
  • Minimum 5 years applicable experience in document control and quality system management where regulatory/FDA compliance and surveillance was required
  • Proficiency in ISO 13485
  • Strong working knowledge of FDA QSR and ISO requirements
  • Possess knowledge and understanding of quality systems, quality controls, quality engineering and regulatory requirements in the medical device industry
 Skills/Competencies:
  • Skilled in organizational development, personnel management, and strategic planning
  • Excellent people skills, with an ability to partner with a dynamic leadership team
  • Possess personal qualities of integrity, credibility, and commitment to company mission
  • Flexible and able to multitask; can work within an ambiguous, fast-moving environment, while also driving toward clarity and solutions; demonstrated resourcefulness in setting priorities and guiding systems
  • Self-motivated, requires minimal supervision for successful completion of projects
  • Change Agent, supports and drives continuous improvement efforts.
 
CERTIFICATION/TRAINING REQUIRED:
Certified Quality Manager or Certified Quality Engineer preferred

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 51 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 disability and life insurance
  • Voluntary vision insurance and other ancillary plans
  • 401(k) plan with employer match
  • Paid vacation and holidays
  • Tuition reimbursement
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