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Quality Manager

4 months ago

Stokesdale, United States Ontex Full time

Ontex is a leading international personal hygiene group. We engineer and make high quality products for Baby Care, Feminine Care and Adult Care and are the partner of choice for consumers, retailers, and institutional and private healthcare providers around the world. We distribute in more than 110 countries through leading retailer private labels, as well as under our own brands.


Job Title: Quality Manager

Schedule: Monday - Friday, 8am - 5pm

Location: Stokesdale, NC

Department: Quality

Reports To: QA Director of North America


Job Responsibilities and Duties

  • Implementation and management of the Corporate Quality System.
  • Lead and manage the quality management system throughout the site.
  • (Manufacturing, maintenance, Supply Chain, other function like R&D , sales teams …)
  • Conformance with regulations, Corporate Quality System requirements and commitments to meet customer requirements.
  • Have a longer-term view on quality performance and quality improvements.
  • Timely management and effective closure of CAPA's related to nonconformance, deviations, complaints, out of specification results and internal and external audits.
  • Drive zero defect mindset in all key performance areas of quality to include recalls, nonconformances, complaints and audits.
  • Manage and develop a strong change management culture to allow product, process and procedural changes to take place without impact on the quality performance.
  • Drive first time right validation process.
  • Create and manage a center of excellence for quality.
  • Ensure the quality policy is established.
  • Ensure the quality policy is understood, implemented and maintained at all levels of the organization.
  • Manage activities required to meet quality management systems.
  • Setting goals for the sites quality performance through establishing KPIs.
  • Ensuring use of best practices within quality management .
  • Identifying opportunities to enhance the overall quality performance .
  • Coaching and developing the quality staff, and holding them accountable for delivery of results.
  • Overseeing and coordinating the release of finished products to the market and managing deviation process. Issue quality approvals.
  • Overseeing and coordinating the consumer complaint handling process in line with market and regulatory requirements .
  • Overseeing and coordinating the quality certification program for the site .
  • Leading the development of the department annual budgeting process and continuously monitoring performance versus budget.
  • Analyze the results of process and product performance monitoring and report findings to site and senior management.
  • Local execution of the Forest Stewardship Council (FSC) and Programmer for the Endorsement of Forest Certification (PEFC) site procedure.
  • Monitor conformance of the customer quality agreement.
  • Ensure change management and validation protocols are implemented and executed.
  • Ensure test methods and specifications are issued and executed.


Different Departments I Will Be Working With

  • The quality department daily to ensure quality management systems are executed.
  • The production department daily to ensure the product is produce within the established specifications.
  • The maintenance department daily to communicate nonconforming observations.
  • The receiving department daily to inspect and receive raw materials.
  • The purchasing department daily to confirm the process order.


Educational Requirement

  • Bachelor of life science degree, preference to Master’s degree. Preference to holder of Certified Quality Engineer Qualification.


Prior Work Experience Requirement

  • Minimum 5+ years’ experience in quality in related industry; preference to candidate with supervisory experience.
  • Minimum of 5+ years’ experience working with organizations regulated by ISO, FDA/EPA and GMP regulations, plus proven track record of building and developing a quality group.
  • In-depth knowledge on quality management and product and process knowledge.
  • Fluent in data analysis and capable of drawing conclusions.
  • Understands how to drive performance improvement across working groups to achieve high performance.


Technical Experience Requirement

  • Trained in auditing quality and environmental management systems.
  • American Society for Quality (ASQ), Certified Quality Engineer (CQE) or Six Sigma Black Belt preferred.


Core Competencies For The Job

  • Strong interpersonal and leadership skills to influence and build credibility as a "peer".
  • Visionary and execution driven mindset.
  • Analytical and organizational skills.
  • Must be able to work with minimum supervision.
  • Highly developed communications skills. Effective written and verbal communication skills.
  • Ability to handle confidential information and communicate with all levels of management.
  • Ability to work outside regular business hours as required.


Company Benefits

  • 401(k)
  • Health, Dental and Vision Insurance
  • Flexible spending account
  • Health savings account
  • Life insurance
  • Paid time off
  • Referral program of $2,000