Overview
Quality Assurance Specialist Jobs in Ventura, California, USA at AVITA Medical
This range is provided by AVITA Medical. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$60,000.00/yr – $80,000.00/yr
Additional compensation types
Annual Bonus
Sr. Vice President of Human Resources at Avita Medical
Position Title:
Quality Assurance Specialist
Location – Ventura
Reports to:
Quality Assurance Manager
Compensation: 60 – 80K DOE plus annual bonus
AVITA Medical is a therapeutic, acute wound care company leading the development and commercialization of devices and autologous cellular therapies for skin restoration. Our FDA-approved RECELL System technology platform treats patients with thermal burn wounds and full-thickness skin defects and is used for re-pigmentation of stable depigmented vitiligo lesions by harnessing the regenerative properties of a patients’ own skin to create Spray-On Skin cells.
We believe that patients are at the heart of everything we do, our employees are the lifeblood of AVITA Medical, passion is key to making a difference, quality impacts everything we do, and integrity is essential to our success.
Position Summary:
Assist with Avita Medical QMS related Systems (Complaints and NCPs) and support manufacturing quality systems at the AVITA Medical production site. Follow established procedures and policies set forth by AVITA Medical and complete tasks as required.
Key Responsibilities:
Support manufacturing of Silicone and elastomer products.
Assist with tasks associated with Customer Feedback/Complaints process including:
Receipt and input of customer feedback/complaint information into system
Coordination of returns analysis
Maintenance of complaints database
Development of complaint evaluation procedure/process for new product(s)
Assist with tasks associated with non-conforming products (NCP) process including:
Maintenance of NCP (non-conformance) system
Product disposition and root cause analysis
Assist in the maintenance of applicable e-QMS modules
Support maintenance of all quality records and documentation in accordance with the quality manual
Other responsibilities as assigned by supervisor
Job Requirements:
Experience working with Silicone and elastomer products
Strong computer skills:
Microsoft Office (Word & Excel) and Adobe Acrobat
Written and oral communication skills
Ability to work on multiple tasks simultaneously
Ability to work independently and as a member of a team
Familiarity with requirements related to traceability, compliance, risk and product manufacturing
Education/Experience
3 – 5 years’ medical device industry experience
Experienced in applicability of ISO 14971:2019, ISO 13485:2016, EUMDR and 21 CFR 820 regulations.
Experienced in the use of electronic Quality Management Systems and database administration.
AVITA Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment decisions are based on qualifications, merit, and business need.
Your Physical Work Environment Will Require:
The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit, talk, and hear, stand, walk and/or balance, use hands and fingers to type, handle, feel, grasp, push, and pull. Hand-eye coordination necessary to operate computers and various pieces of office equipment. Specific vision abilities required by this job include close vision and the ability to adjust focus
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Title: Quality Assurance Specialist
Company: AVITA Medical
Location: Ventura, California, USA
Category: Quality Assurance – QA/QC
