Job Description

Hygiena is a rapidly growing global life science company that manufactures and sells rapid microbial detection and monitoring solutions to a wide range of industries. 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 Manager, Quality Assurance to join our team! 

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, which includes coordinating inspection activities to ensure product and process compliance to acceptance requirements.  This also includes controlling nonconforming product 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.
• 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.

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.

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. 

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

Why you’ll want to join our team.

Teamwork as a core value.

At Hygiena, our emphasis on teamwork and cross-functional communication enables us to build stronger bonds within our business.

Be a part of something big.

Hygiena plays a critical role in helping to prevent global health crisis such as foodborne illness, healthcare-associated infections, and other outbreaks.

Giving back to our communities.

Hygiena believes in giving back by supporting local organizations committed to improving the lives of children and youth in our communities.

We are an equal opportunity employer and value diversity. All employment is decided on the basis of qualifications, merit and business need. 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.