Senior Global Director, Quality Assurance

1 month ago

Camarillo, United States Hygiena LLC Full time
Job DescriptionJob Description

GENERAL PURPOSE

The Sr. Global Director of Quality Assurance (QA) is responsible for the overall QA function to ensure compliance with established standards of corporate objectives and regulated agencies for industry (ISO and FDA) around the world. This role is also responsible for the planning, development and implementation of quality systems that support the Hygiena manufacturing site objectives. This role has manager responsibility over QA, QC and Doc Control globally.

Responsibilities

Essential functions of the job are listed below. Other responsibilities may also be assigned. Please note that the essential functions may vary depending on department size, organizational structure and/or geographic location. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.

Supervisory Responsibilities

In accordance with applicable policies/procedures and Federal/State laws, may perform the following managerial responsibilities: interviewing, hiring, orienting and training employees; planning, assigning, and directing work; coaching and appraising performance; rewarding and disciplining employees; addressing personnel complaints and resolving problems; enforcing all safety rules and ensuring safe work procedures.

Minimum Qualifications

The following are the minimum qualifications that an individual needs in order to successfully perform the duties and responsibilities of this position. Please note that the minimum qualifications may vary based upon the department size and/or geographic location.

Knowledge

  • Bachelor’s Degree in Engineering (Mechanical or Biomedical Engineering preferred) or related field, or equivalent education and work experience, required.
  • Minimum of 7-10 years’ experience in federally regulated industry to include QA, compliance, and/or Regulatory Affairs.
  • Minimum of 5 years’ experience in a managerial role in a multi business unit setting (global preferred).
  • ASQ Certification (CQE, CRE, CQA, CQM) preferred. Education and/or Experience.
  • Strong working knowledge of QSR, ISO 13485, MDR, and ISO14971 (Risk Management) requirements.
  • Strong knowledge of Microsoft Office (Outlook, Word, Excel, Visio, PowerPoint).
  • Knowledge of Microsoft Navision Dynamics MRP system is a plus.
  • Experience with conducting quality audits (internal and supplier, as well as managing and hosting external audits (e.g. FDA, ISO).
  • Experience in continuous improvement methods such as Six Sigma, Kaizen, or Lean Manufacturing; Lean/Six Sigma Black Belt certification preferred.

Skills/Abilities

  • Excellent verbal and written communication skills
  • Must be a strong team leader, be self-motivated and can motivate others
  • Must be able to multitask and manage multiple projects concurrently
  • Superb listening skills and ability to probe for better understanding of applicable situations
  • Problem solving aptitude to accurately define, analyze, and solve complex problems or breakdowns in a process or the QMS.
  • Must be able to delegate and manage workload within the department
  • Must be able to adapt and flex to a changing environment during times of rapid growth and shifting priorities
  • Must be able work well under pressure and be able to make decisions

WORKING Conditions

  • May occasionally be required to travel.
  • May occasionally work evenings and/or weekends.
  • Able to establish working partnerships with other functional managers as applicable.

PHYSICAL DEMANDS

In general, the following physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.

  • This position is considered light work - exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.
  • Required to have close visual alertness to view computer screens or complex 2D drawings for component compliance.
  • Frequently required to maintain a static position or repetitive motions during training.
  • Must be able to gown in a regulated clean room setting (Basic 5-piece lab garments under cGMP).

WORK ENVIRONMENT

In general, the following conditions of the work environment are representative of those that an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job within the environment.

  • The work environment is fast-paced at times and adaptability is a must.
  • Vigilance of direct reports to ensure tasks/projects are on track.
  • Work environment is not substantially exposed to adverse environmental conditions.
  • Occasional need to gown in a clean room environment (Basic 5-piece lab garments under cGMP).

Disclaimer: This is not necessarily an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the job. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned. This job description does not constitute a contract of employment and that the company may exercise its employment-at-will rights at any time.

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