Quality Assurance Specialist

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Full-time Regular Professional Camarillo, CA, US

3 days ago Requisition

Salary Range: $70,304.00 To $85,000.00 Annually

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!

• 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.

• 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 including experience within 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.

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

• Comfortable 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.
• Multi‑tasking capabilities.
• Must have in‑depth analytical and problem‑solving skills.
• Must be able to use discretion and independent judgement.

• Required to work normal office hours (with some flexibility as per the below) Monday through Friday in the office.

• 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 and/or leg controls requires exertion of forces greater than that for sedentary work and the employee sits most of the time, the job is rated for light work.
• Required to have close visual acuity to perform an activity such as viewing a computer screen.
• Frequently required to maintain a static position, talking, hearing, seeing and repetitive motions.

• 15 days of PTO & 9 paid company holidays.
• Medical with HSA employer contribution, Dental, Vision available 1st of the month after start date.
• Company paid Life Insurance, Short‑term and Long‑Term Disability and an Employee Assistance Program.
• 401(k) with Safe Harbor and Profit‑Sharing employer contributions.
• Tuition Reimbursement program.
• Charitable Contribution matching.
• Employee Referral bonus opportunities.

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.