Hygiena provides rapid microbiology diagnostic tests and solutions for mission-critical, time-sensitive processes around the world. Hygiena’s proprietary diagnostic technologies enable customers to; prevent illness and save lives, comply with regulations, protect products and brands, run businesses more effectively. Solutions are sold in a wide range of industries globally, but the core focus is food safety. Headquartered in Camarillo, California and with offices around the world, we are actively looking for talented individuals to help grow the business!

At Hygiena we believe:

• In providing the highest quality products & service
• Being a leader in innovation
• Having a compelling desire to improve and win in the marketplace
• In contributing positively not only in the workplace, but in our community and environment!

With rapid growth comes opportunity. We are looking for a Senior Global Director, Quality Assurance to join our team in Camarillo. This is a full-time position.

Responsibilities:

• Leads, directs, and manages Quality Assurance, Quality Control and Document Control functions, Safety initiative, and the chemical regulatory compliance; this includes performance management, staffing needs and ongoing development and feedback for team members.
• Supervises the Quality Inspection Department in the US and Globally which includes coordinating inspection activities to ensure product and process compliance to acceptance requirements.  This also includes controlling nonconforming products and coordinating final product acceptance/release activities.
• Maintains an efficient customer complaint system to ensure complaints are investigated and resolved in a timely manner.  Ensures team members of all relevant functions are aware of any changes or issues discovered from complaints and proper corrections are taken.
• In partnership with facility quality leaders, collaborates to identify best practices and implement processes aimed at improving quality results. Develops, implements and maintains quality systems to ensure FDA and ISO compliance.  Ensures policies and procedures are reviewed and updated to meet current regulatory standards; documents applicable changes and educates team as needed.
• Optimizes quality systems to effectively identify, measure and reduce cost of quality activities. Acts as site champion of Operational Excellence, suggests and implements continuous improvement ideas throughout the value streams.
• Responsible for all aspects of environmental programs, employee health and safety, developing, planning, establishing, implementing, and maintaining all health, safety and environmental programs to assure regulatory compliance as well as the highest possible degree of safety for our employees and the environment. Also responsible for leading environmental and safety compliance initiatives, as well as chairing and conducting quarterly safety committee meetings.
• Oversees and maintains effective audit programs, including internal and supplier compliance audits, as well as external audits (FDA, ISO, environmental, etc.). Manages the Material Review Board process for Hygiena.
• Maintains an effective Quality Management System (QMS); facilitates Management Review meetings and related data analyses.  Engages with related functional managers on creating/updating procedures, work instructions, specifications, and test methods per QMS requirements.
• Oversee establishment of manufacturing quality plans for transferring product designs to manufacturing.
• Oversees process validation activities, including calibration and GMP training programs.
• Serves as functional liaison for new product development activities.  Actively participates in product design reviews, design and process FEMA’s and oversight of quality new product development activities.
• Actively supports and participates in the safety program, both for self-protection and the protection of other employees, by reading and abiding by all requirements in the Safety Manual and Injury Illness Prevention Program (IIPP).
• Carries out all responsibilities in an honest, ethical, and professional manner.
• Must be able to fulfill essential job function in a consistent state of alertness and safe manner.
• Handles various other duties as delegated by COO.

Qualifications:

• 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.

Salary Range (applicable to California):

$160,000 - $210,000 DOE

Supervisory Responsibilities:

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

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