Principal Quality Engineer
22872 Avenida Empresa Rancho Santa Margarita, CA 92688 US
Job Description
Overview:
This Principal Quality Engineer is highly visible opportunity for a Subject Matter Expert in Quality Operations.
Responsibilities:
- Demonstrated ability to provide leadership to a team of direct reports within the Quality organization.
- Monitor and ensure compliance to internal Quality System and external industry regulations
- Maintain current and develop new or revised internal processes, procedures and documentation related to all phases of product realization and related internal processes
- Provide engineering support and guidance to other stakeholders with respect product and manufacturing/process improvements
- Lead reviews of new or current Risk Reduction Assessments and root cause analyses for products and related processes; helping to ensure cross-functional implementation for risk reduction approaches and practices in all phases of product realization and related processes in compliance with ISO 14971/ISO 24971
- Oversee and help ensure proper implementation and reporting of regular sterilization cycle dose auditing and regular bioburden testing of product which utilizes Gamma Irradiation
- Provide guidance and assist Product Development with Design Control activities such as Design and Process Changes/Improvements, COGS reduction, risk assessment, protocol/report (V&V) writing, and data analysis
- Support Customer Complaint, CAPA and NCMR functions such as root cause analysis and failure investigations, product dispositions, risk assessments, and write-up of associated reports
- Lead MRB process, provide statistical trending and data-based outcome analyses for all critical components, nonconformance data from incoming and in-process activities, and generate regular and ad hoc reports for communication to department management and other Company stakeholders
- Maintain Inspection and Quality Control procedures
- Take a lead role in Supplier Management QA activities including qualification, monitoring, problem resolution of and with critical component suppliers
- Maintain Equipment Calibration and preventive maintenance including requisition and qualification of existing and new equipment
- Participate in internal audit activities, including planning, execution, and reporting of internal audits
- Identify and make recommendations to Department Management for Quality System and product improvement opportunities
- Perform related duties as assigned by supervisor
- Maintain compliance with Quality System procedures and company policies
Qualifications:
- Minimum B.S. in engineering, life science or related discipline. American Society of Quality Certified Quality Engineer (ASQ CQE) a plus
- At least twelve (12) years work experience in a regulated industry (medical device preferred)
- At least twelve (12) years work experience in quality engineering or quality assurance
- Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers
- Excellent computer proficiency (MS Office – Word, Excel and Outlook)
- Strong knowledge of Risk Management discipline and must be able to apply quality principles (GMPs, 21 CFR 820, ISO 14971:2012, IEC 60601, ISO 13485, EN 62304, and IEC 62366) to Design Controls
- Ability to lead multi-disciplinary teams
- Demonstrated knowledge of statistical methods and principles
- Ability to create and maintain project plans
- Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary customer service
Meet Your Recruiter
Alexis Cabero
Branch Manager
As Branch Manager, Alexis Cabero focuses on identifying talent for a variety of industries including medical devices, administrative support, customer service, engineering, and human resources. Graduating from The University of California, Irvine with a B.A. in Arts and Digital Media, Alexis’ recruiting career began in 2014 while staffing for assisted living facilities, where she matched passionate healthcare professionals to provide personal non-medical care for home care clients. Alexis is passionate about helping others recognize their potential, and does so by using a thorough discovery process with her candidates to better understand what areas they excel in and providing opportunities exclusive to Marquee Staffing.
While out of office, Alexis enjoys spending her free time with family and her six dogs.