Quality Manager

Job Locations US-NC-Asheboro
Posted Date 1 week ago(3/13/2018 4:01 PM)
Job ID
# of Openings


The Quality/Regulatory Affairs Manager must work closely with all departments to assure that all products meet the requirements of the customer and quality system.  Liaison for Customer, Supplier and company to assure that customer requirements are understood and met.  It is the responsibility of the Quality/Regulatory Affairs Manager to present the Quality Management System to the employees, current and potential customers, external auditing agencies (e.g., FDA, ISO, etc.) and Executive leadership as required.  Responsible for overseeing the quality system for ISO 13485 certifications.


  • FDA Registrant/Representative.
  • Appointed as Management Representative who, irrespective of other responsibilities, has the responsibility and established authority for ensuring that all processes needed for the quality management system are established, implemented and effectively maintained in accordance with ISO Quality Management System and regulatory requirements (i.e. 21 CFR 820). Reporting to top management on the performance of the quality management system and any need for improvement.
  • Ensuring and promoting awareness of 21 CFR Parts 210 and 211 – cGMP in Manufacturing, Processing, Packaging or Holding of Drugs and Finished Pharmaceuticals.
  • Leads and directs Quality Services, Inspection, Final Audit/Test, and Staff in matters concerning system compliance.
  • Member of the Material Review Board for nonconforming materials.
  • Assists all personnel and Manufacturing Manager on quality and regulatory matters.
  • Promoting quality achievement and performance improvement throughout the organization.
  • Establishing QA compliance objective and ensuring that targets are achieved.
  • Assesses product specifications of the company, its supplies, and compares it with customer requirements.
  • Working with purchasing to establish quality requirements from external suppliers.
  • Ensuring compliance with national and international standards and legislation.
  • Considering the application of environment and health and safety standards.
  • Establishing clearly defined quality methods for staff to apply.
  • Defining quality procedure in conjunction with operating staff.
  • Establishing and maintaining controls and documentation procedures.
  • Identifying relevant quality-related training needs and delivering training.
  • Collating and analyzing performance data and charts against defined parameters.
  • Supervising staff in carrying out tests and checks.
  • Ensuring tests and procedures are properly understood, carries out and evaluates and that product modifications are investigated, if necessary.
  • Writing technical and management systems procedures and reports.
  • Meeting with staff of different disciplines and driving the group to plan, formulate and agree on comprehensive quality procedures and working to incorporate quality methods.
  • Liaising with customers, suppliers and auditors in ensuring the execution of corrective action and compliance with customers specifications
  • Supports the Safety Committee and its functions.
  • Ensure that all department employees receive the appropriate training.
  • Ensure all CAPA’s assigned to the Quality department are investigated and complete adequately and on schedule.
  • Ensures that internal audits assigned to a person in the quality department are completed adequately and on schedule.
  • Performs any other duties assigned by management.


Required Competencies, Skills and Experience

  • Working knowledge of ISO9001 quality management systems.
  • Experience working in ISO13485 environments.
  • Familiarity with FDA regulations and procedures to ensure compliance.
  • Food Industry Experience.
  • Working knowledge of ERP operating systems.
  • Strong knowledge of Microsoft Office applications.
  • Analytical - Collects and researches data; Uses intuition and experience to complement data.
  • Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations.
  • Customer Service - Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments.
  • Interpersonal Skills - Focuses on solving conflict, not blaming; Remains open to others' ideas and tries new things.
  • Oral Communication - Listens and gets clarification; Responds well to questions; Participates in meetings.
  • Written Communication - Writes clearly and informatively.
  • Teamwork - Gives and welcomes feedback; Supports everyone's efforts to succeed.
  • Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
  • Cost Consciousness - Works within approved budget; Develops and implements cost saving measures; Contributes to profits and revenue; Conserves organizational resources.
  • Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values.
  • Judgment - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
  • Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles.
  • Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives.
  • Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
  • Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
  • Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity.
  • Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
  • Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
  • Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
  • Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments.
  • Initiative - Volunteers readily; Takes independent actions and calculated risks; Asks for and offers help when needed.


Preferred Skills


  • Working knowledge of injection molding operations.


Education and Job Experience Requirements


  • Bachelor’s degree in engineering, industrial management or equivalent degree.
  • Two to three years job-related managerial experience in Quality, in a manufacturing environment.


Work Environment and Physical Demands

  • The position requires the ability to work in non-climate controlled and climate controlled plant areas and climate controlled office areas.
  • This position is exposed to noisy plant areas, and forklift traffic.
  • This position requires the ability to walk on concrete floors, lift up to 30 pounds, perform repetitive keystrokes on a continual basis, and occasionally bend, kneel, twist, and reach.
  • While performing the duties of this Job, the associate may be exposed to moving mechanical parts.
  • The employee is occasionally exposed to fumes or airborne particles.
  • Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
  • Position requires the abilities to walk, sit, stand, lift and carry up to 50 pounds; ability to hear, understand and convey verbal communications of and to other personnel.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.


The work environment and physical demands detailed above are representative of those encountered while performing the essential functions of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.


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