Top Job
Located in San Clemente, CA
Salary: $100K-$120K
Express Employment Professionals, Laguna Hills is recruiting Quality Assurance Manager for a Medical Device Manufacturing company located in San Clemente.
Temp/Contract, Fulltime
Pay: Up to $120K DOE
Schedule: M-F 1st Shift
Responsibility:
The main responsibilities within the role of the Quality Assurance Manager will be to ensure the highest standards are met in accordance with regulatory requirements and/or stated standards (ISO & FDA); to continuously improve our quality reporting processes; to manage the team to ensure quality assurance results are maintained and produced in a timely manner; to control, review and challenge our quality associates on customer standards to ensure compliance by providing advice and support.
Key Responsibilities:
- Responsible for site regulatory compliance
- Ensure maintenance and implementation of Quality Systems and training
- Act in conjunction with Plant Manager as technical contact on quality-related issues
- Address customer concerns, applying root-cause analysis and problem-solving skills
- Aid in development of suppliers and implementation of Quality Systems Documentation including training documentation and providing appropriate training
- Lead audits by Third-Party Registrars/Customers
- Fully support and work with all departments to ensure quality standards are upheld
- Provide leadership within the daily QA activities and promote a Quality culture throughout the facility.
- Support utilization of ISO and QMS systems cost-effectively
- Utilize APQP/PPAP, process flow maps, FMEAs, control plans and measurement system evaluations to support Quality Standard requirements
- Ensure Quality documentation is current with Corrective Actions (PFMEA, Control Plans, Flow Charts, etc)
- Manage and report key Quality Performance Metrics
- Work with other disciplines to ensure the integrity of an ISO Class 8 cleanroom
- Promote company Core Values with key focus on Safety
- Assist with other various duties as assigned by management
Job Qualifications
- Must possess degree of Science or Business or similar, with 5-10 years’ experience in Quality Assurance in a manufacturing environment
- Must have a thorough understanding and working knowledge of ISO 9001:2015 and ISO 13485:2016 standards.
- Must be a certified Lead Auditor.
- Must have experience managing third party regulatory and customer audits.
- Must have thorough understanding of QA/QC theory, procedures and practices, including potential failure modes for company product lines
- Must have basic understanding of manufacturing processes and operation systems
- Must have ability to negotiate and communicate successfully at all levels
- Must possess strategic planning and development skills
- Must have extensive knowledge of measuring/test equipment, gauging practices and capability of undertaking full GR&Rs
- Must possess working knowledge of computers, software applications (at least: Word, Excel, Visio, Access and Outlook) and excellent reading/comprehension skills
Benefits of working with Express include medical benefits, training, and scholarship opportunities.
Apply with application to jobs.lagunahillsca.expresspros.com or email your resume to Lagunahillsca@expresspros.com or contact us at 949-556-3359
2766ST
Express Office: Laguna Hills
23181 Verdugo Drive
Suite 104-B
Laguna Hills, CA 9265
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