Quality Assurance Specialist

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 Quality Assurance Specialist to join our team in Camarillo! This is a full-time exempt position.

Responsibilities:

• Standardize and continuously improve the Quality Management System (QMS) to ensure full compliance with regulatory requirements and industry standards. Draft, revise, and control critical quality documents, technical specifications, and operational forms in collaboration with management.
• Maintain and manage daily quality processes, including nonconformances, deviations, change controls, and risk assessments. Drive Corrective and Preventive Action (CAPA) and Supplier Corrective Action Requests (SCAR) from initial investigation and root-cause analysis through to action tracking, effectiveness verification, and closure.
• Support validation protocols (IQ/OQ/PQ) for production equipment, software, manufacturing processes, and utilities. Develop and maintain comprehensive validation documentation, final reports, and traceability records to ensure floor operations remain fully compliant with internal procedures.
• Participate in internal audits, supplier audits, and external audits/inspections as assigned; assist with audit preparation, documentation, and follow-up activities.
• Support complaint handling and investigation activities, including data collection, trend analysis, documentation, and escalation of quality issues when appropriate.

Qualifications:

• Bachelor's Degree in Science, Engineering, Business or a related field required
  • ISO 9001 or ISO 13485 Lead Auditor Certification preferred

• Minimum of two (2) years of direct, hands-on experience working in a fast-paced manufacturing or production environment required that includes the following:
• Experience with in an ISO certified facility, preferably with ISO 9001 and/or ISO 13485
• Demonstrated experience executing root cause investigations, facilitating Corrective Action (CAPA), and handling customer complaint investigations

• Intermediate knowledge of Microsoft Office (Outlook, Word, Excel, Visio, PowerPoint) and Adobe Acrobat required.

Salary Range (applicable to California):

$70,304-$85,000 base salary DOE

Skills/Abilities:

• Comfortable with interacting and working with all levels of customers, both internal and external; good interpersonal skills, team motivation and outgoing personality
• Excellent adaptability in a fast-paced environment with the flexibility and willingness to take on new tasks and projects
• Ability to speak and write clearly and accurately
• Attention to detail and accuracy
• Effective listening skills
• Multi-tasking capabilities
• Must have in-depth analytical and problem-solving skills.
• Must be able to use discretion and independent judgement.

Working Conditions:

• Is required to work normal office hours (with some flexibility as per the below) Monday through Friday in the Office

Physical Demand:

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. If the use of arm…