- 3601 Calle Tecate, Camarillo, CA 93012, USA
Technicolor Home Entertainment Services optical disc technology development, first-rate capabilities for precision mastering of micro-/nano-scale features and subsequent precision molding of polymer replicas provides a world class platform to address the foremost challenges in microfluidic Lab-on-Chip consumable manufacturing. To enter into this exciting market opportunity, we established Technicolor Precision BioDevices, a new operating division within Home Entertainment Services. Technicolor’s existing worldwide manufacturing facilities and supply chain infrastructure are ideally suited to support the rapidly growing market for lab-on-chip and other microfluidic/diagnostic devices.
We’re seeking an experienced Quality Engineer who wants to work with a highly interactive and dynamic team in our dedicated Microfluidics Innovation Center to provide support across engineering and operational activities to facilitate an environment of compliance and successfully meeting business objectives. Are you looking to serve as a key member responsible for ensuring manufacturing and support activities meet requirements of 21CFR820, ISO 13485, and applicable In Vitro Diagnostic medical device regulations? Do you want to be part of a business venture who manufactures devices that could provide a life changing difference in the medical diagnostic field? If so, join us for these exciting times!
Essential Functions of Position - Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Primary responsibility is for Process and Equipment Validation activities
- Supporting the inspection process throughout product realization, final product release activities, and ensuring Design History Record requirements are met
- Primary responsibility for administering the Nonconformance (NCMR) program
- Developing and leading Calibration and Maintenance programs for equipment, as applicable
- Supporting responsibility for managing the Risk Management, Corrective and Preventive Action (CAPA), and Supplier Management program(s) meeting external and internal requirements
- Supporting the authoring and revision of QMS documentation, preparing information for management reviews, participating in first-, second- and third-party audits as required
- Lead improvement projects within the QMS through supportive tools, databases and project plans
- Author, maintain, and present quality objectives through data exporting and metrics with professional presentations
- Assisting in investigation of product quality and customer product complaints, identification of root cause, and implementation of correction and corrective actions
- Assisting in the design and development of methods and tooling for the measurement, testing and inspection of products to support acceptance
- Bachelor’s degree in a related field or equivalent relevant work experience
- Minimum 4 years’ experience with an established medical device or IVD QMS including extensive experience in the following areas:
- Authoring and executing validation protocol and reports
- Managing and administering improvement processes in accordance with 21CFR820 and ISO 13485
- Administering CAPA database
- Statistical analysis for use in various QMS processes
- Experience preparing for and participating in internal and external audits
- Experience authoring QMS documentation
- Advanced proficiency with the Microsoft Office Suite
Additional Eligibility Qualifications:
- Ideally have worked in a small company/start up environment with successful track record of new products/services introductions in a dynamic market environment
- Excellent verbal and written professional communication and presentation skills
- Strong technical writing skills
- Supplier assessment and approval through site audits a plus
- ASQ Certified Quality Engineer and/or Certified Quality Auditor certification desired
Why Work With Technicolor?
- A safe and clean work environment
- A culture of innovation, collaboration, and teamwork
- Training and opportunities to grow within the company
- Employee discounts and paid holidays, vacation, and sick time
- Discounted homeowner’s, renter's, pet, and car insurance
- Medical, dental, vision benefits (comprehensive coverage with low premiums)
- We offer a 401k match and provide life insurance at no cost to our employees!
Work Environment/Physical Requirements
This job operates in a professional office and device lab environment. This role routinely uses standard office equipment such as laptop computers, phones, photocopiers, filing cabinets, and smartphones. While in clean-room environment must wear clean-room garments, masks, boots, and protective equipment. Frequently exposed to chemicals, fumes and particles, moderate noise and vibration. Frequently works near moving mechanical parts, electrical components.
While performing the duties of this job, the employee is regularly required to communicate (verbal/written), converse with, and exchange information with others. The employee is frequently required to remain in a stationary position for long periods of time; occasionally move between their workspace, office machinery, and mechanical equipment. The person in this position must operate a computer and other office machinery such as a copy machine, printer, calculator; pull/retrieve/file documents in a filing cabinet. Occasionally move about inside the facility to converse with co-workers and monitor production; may need to position oneself to move between tight, high, or low spaces. Frequently required to handle/position delicate objects, machinery, tools and/or controls. Seeing abilities required by this job include detecting/identifying/recognizing/inspecting objects close to the employee, within a distance, peripherally, depth perception and the ability to adjust focus.
TECHNICOLOR IS AN EQUAL OPPORTUNITY EMPLOYER
Applicants are considered for employment without regard to race, religion, creed, color, national origin, ancestry, medical condition (including genetic characteristics), mental and/or physical disability or handicap, marital status, sex, age, veteran status, citizenship status, sexual orientation, gender identity, political party preference, political belief, socioeconomic status, familial status, registered domestic partner status, military service, pregnancy, childbirth and related medical conditions and any other characteristic or activity protected by federal, state or local law.
All your information will be kept confidential according to EEO guidelines.