Supplier Quality Auditor - Glidewell Laboratories

Supplier Quality Auditor

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Position Reports To: Designated Manager or Supervisor

Position Directly Supervises: No one

Job Division: RA/QA

Over-time Status: Exempt

Purpose Of Position: To ensure products are developed and manufactured according to quality procedures and meets all applicable specifications and requirements.

To fulfill this position successfully, an individual must be able to perform each essential function satisfactorily.

Essential Functions:

  • Tracks and determines supplier’s qualifications according to organization's standards; reports supplier performance and quality to management.
  • Plans, directs, and approves supplier validations, capability analyses, and gage studies based on risks identified in FMEAs
  • Manages supplier-related non-conformances and supplier corrective actions reports (SCAR’s) from initiation to closure.
  • Oversees and develops supplier metrics such as but not limited to PARETO charts and/or control charts.
  • Assess Supplier Management, QA Management system, and SOP’s improvement.
  • Drives deliverables to obtain supplier approval.
  • Maintains successful relationships with supply, engineering, manufacturing, and regulatory departments.
  • Assists in the development and implementation of supplier management programs.
  • Develops and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
  • Designs or specifies inspection and testing mechanisms and equipment, conducts quality assurance tests, and performs statistical analysis to assess the cost and determines which products or materials that do not meet required standards and specifications
  • Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements
  • Conducts onsite supplier audits.
  • Performs other related duties and projects as business needs require at direction of management.

The preceding functions have been provided as examples of the type of work performed by employees assigned to this job classification. Management reserves the right to add, subtract, or change the job functions.

Minimum Qualifications: The requirements listed below are representative of the knowledge, skill, and ability necessary to successfully perform the essential functions of the position.

  1. Education and Experience:
  • Bachelor’s degree in Science or a related field or an equivalent combination of experience and training.
  • Minimum four (4) years’ experience in Quality, Manufacturing, Engineering or related field within the medical device industry; cross industry experience a plus.
  • Previous experience performing GMP/ISO and Service audits.
  • Previous experience in root cause analysis and corrective and preventive action methods.
  • Previous experience in project management.

Special Requirements/Certification:

  • ASQ, CQE, or other certifications preferred

Communication Skills:

  • Demonstrated proficient English communication skills, both written and verbal.
  • Demonstrated strong interpersonal skills and capability to effectively communicate with all levels of the Company.
  • Demonstrated consultative and relationship management skills.
  • Demonstrated active listening skills.
  • Must be able to effectively present material to large and small groups.
  • Ability to establish productive working relationships with individuals of all levels.
  • Ability to communicate effectively in a multi-cultural business environment.

Knowledge, Skills, and Abilities:

  • Knowledge of and adherence to Quality systems.
  • Proficient knowledge of general office procedures.
  • Knowledge and understanding of policies, procedures, and guidelines relevant to quality compliance.
  • Proven expertise in MS Office Suite (Excel, Word, Outlook, and PowerPoint).
  • Demonstrated problem-solving, critical thinking, and investigate skills.
  • Demonstrated attention to detail and accuracy.
  • Ability to manage confidential information with discretion.
  • Ability to interact professionally with all organizational levels.
  • Ability to manage competing priorities in a fast paced environment.
  • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.

Physical Demands: The physical demands listed below are representative of those that must be met by an employee to successfully perform the essential functions of this position.

§ Ability to frequently bend and/or twist at waist/knees/neck to and from seated position while working at desk/bench and reaching for equipment.

§ Ability to frequently use standard office equipment such as but not limited to computers, telephones, copiers, and scanners.

§ Ability to frequently communicate with others.

§ Ability to maintain long periods of mental alertness and attention to detail while setting priorities, meeting critical deadlines, and following up on assignments.

§ Ability to constantly perform sedentary work, spending extended periods of time at desk or workstation.

§ Ability to seldom stand and/or walk for extended periods of time.

§ Ability to seldom climb stairs at some locations.

§ Ability to seldom push and/or pull up to five (5) pounds.

§ Ability to frequently lift or carry up to five (5) pounds.

§ Ability to keyboard for extended periods of time.

§ Ability to function in an environment with frequent interruptions.

§ Ability to deliver quality results under high pressure deadlines in a fast-paced environment.

  • Ability to frequently travel to locations away from primary workplace as necessary.
  • Ability to frequently travel to domestic and international locations.

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this position.

  • Primarily an office setting environment with moderate noise levels and no direct exposure to hazardous physical substances.