Senior Quality Engineer job responsibilities include:
- Work closely with Regulatory, R&D, Quality and Manufacturing, to ensure the highest quality products and processes are being developed and deployed.
- Ensure that process and equipment improvements/upgrades are properly validated and placed into production so that resulting product can be produced with the required quality and repeatability.
- Perform/support engineering analysis of the product performance post-market release using quality inputs such as external defect rates, returns, and line rejects, customer feedback, feedback from regulators, and observations from audits/inspections.
- Provide leadership/support and direction for activities supporting complaint and CAPA investigations; ensure timely completion with all assigned activities.
- Provide leadership/support and be accountable for support for CAPA"s, Health Hazard Evaluations, Field Corrective Actions, Nonconforming Materials processes, and quality systems related responsibilities.
- Lead/Participate in internal quality audits.
- Lead/Participate in Risk analysis and management.
- Deploy and utilize Statistical Process Control (SPC), where applicable.
- Assist in the development and implementation of final product testing.
- Perform statistical sampling, as needed, to ensure product quality and process performance.
- Support the onboarding of new suppliers (supplier audits included).
- Support MRB and NCMR evaluation, investigation and dispositions.
- Bachelor of Science in Mechanical Engineering or related Engineering field required. "Master"s degree" Preferred
- Minimum 5 to 7 years in QE role in product design and development, preferably in a Class II or III medical device environment.
- Solid understanding of design control, US FDA QSR, ISO 13485, EU MDD/MDR, MDSAP, CMDCAS, Brazil RD, Australia TGA, Japan PAL, ISO 14971 and other applicable standards and regulations.
- Working knowledge of statistics and statistical packages (MiniTab) and design software (solid works).
- Regulatory Affairs Certification (RAC) or CQE (Certified Quality Engineer).
- Proven experience with lean manufacturing and six sigma processes.
- Experience related to the regulation of Class II and III medical devices.
- Knowledge of cleanroom and terminal sterilization processes and requirements.
If you are interested in this Senior Quality Engineer job in Thousand Oaks, CA then please click APPLY NOW. For other opportunities available at Acara Solutions go to www.acarasolutions.com. If you have questions about the please contact Robert Schemel at 763-560-8023 or email@example.com.
Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct, and Aleron's strategic partner, SDI) are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis. The Aleron companies welcome and encourage applications from diverse candidates, including people with disabilities. Accommodations are available upon request for applicants taking part in all aspects of the selection process.
Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.