Quality Engineer

Job Description

Job Description

Quality Engineer

Role is on-site in Camarillo, CA

$90-110k / year DOE

• SUMMARY :

The Quality Engineer works closely with Operations, Manufacturing Engineering, R&D and Quality teams across the organization to lead and drive quality through process improvement assessment and continuous improvement. The Quality Engineer will be the key point of contact for quality-related issues in process nonconformance, manufacturing workflows and quality providing leadership in project management and technical areas for improvements and enhancements of process and testing requirements. The Quality Engineer will be the primary contact responsible for quality events related to in-the-market defects and their corresponding root cause analysis and CAPA (Corrective Action & Preventative Action).

Bachelor’s degree in Business, Sciences or Engineering

5+ years of experience in quality operations within a biotechnology or pharmaceutical manufacturing facility.

5+ years of experience with technical documentation for complex activities in the areas of the Quality System that includes corrective actions, change control, quality audits and validation of manufacturing processes, or product development in a pharmaceutical or medical device environment.

Strong understanding of global pharmaceutical and biotechnology product regulations with ISO 9001 and / or 13485 : 2003 and 21 CFR Parts 210 and 211 and / or Part 820.

Able to drive continuous improvement through collaboration and consensus building.

Proficient problem-solving skills using continuous improvement tools; certification desired in ASQ, Green Belt, Lean, or equivalent.

Demonstrated proficiency in multiple quality systems including exception management, change control, document control, product release, etc. with strong decision-making skills utilizing risk management.

Quality System Knowledge (e.g. ISO 9001, ISO 13485).

Advanced skills with MS Office software are preferred.

Equal Opportunity Employer / Disabled / Protected Veterans

The Know Your Rights poster is available here :

https : / / www.eeoc.gov / sites / default / files / 2023 -06 / 22- 088_EEOC_KnowYourRights6.12.pdf

The pay transparency policy is available here :

https : / / www.dol.gov / sites / dolgov / files / ofccp / pdf / pay - transp_%20English_formattedESQA508c.pdf

For temporary assignments lasting 13 weeks or longer, the Company is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.

We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.

AppleOne participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.

https : / / e- verify.uscis.gov / web / media / resourcesContents / E - Verify_Participation_Poster_ES.pdf

We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants : Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

#1111

Company Description

This company offers growth and a great group of people to work with.

Company Description

This company offers growth and a great group of people to work with.