Quality Assurance Specialist
About The Position
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.
Requirements
- Bachelor’s Degree in Science, Engineering, Business or a related field required
- 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 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.
Nice To Haves
- ISO 9001 or ISO 13485 Lead Auditor Certification preferred
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.
- Ensures compliance with and/or follows all organizational systems, programs, training, policies, and procedures as required and complies with relevant legal mandates. Seeks guidance as necessary.
- 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 the department manager.
Benefits
- 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 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
- State paid short-term disability for California based employees
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
