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Urgent! Quality Engineer Job Opening In San Clemente – Now Hiring Actalent
Job Title: Quality Engineer
** For Immediate consideration please apply to this posting and email your resume to habels@actalentservices.com**
Job Description
We are seeking two mid-level Quality Engineers or a Principal Quality Engineer to join our team.
This role is pivotal in ensuring our quality system meets top standards and that our products comply with regulatory and company guidelines.
You will collaborate with various teams to ensure smooth and efficient operations.
Responsibilities
+ Guide and oversee product and process validations, including sterilization validation and revalidation.
+ Lead biocompatibility studies to ensure our products are safe.
+ Create and update Risk Management documents for new products or design changes, adhering to ISO standards.
+ Represent Quality Assurance on project teams for new or revised products.
+ Investigate product or production issues and develop corrective actions.
+ Oversee and maintain our Calibration and Preventive Maintenance Systems.
+ Evaluate, develop, and monitor suppliers to ensure compliance with standards.
+ Support the maintenance of our quality system in line with our Quality Policy and regulatory standards.
+ Provide support for regulatory submissions and audits.
+ Hold signature authority for changes to manufacturing/quality procedures, processes, and designs.
+ Provide training and direction for Quality Inspectors and Technicians.
Essential Skills
+ Bachelor's degree required.
+ 5+ years of experience as a Quality Engineer within the Medical Device or Biotechnology field.
+ Expertise in risk management, ISO standards, sterilization, and quality engineering.
+ Hands-on approach in quality assurance, biocompatibility, cleanroom management, and cardiovascular device development.
+ Proficiency in regulatory compliance, design control, process validation, and root cause analysis.
Additional Skills & Qualifications
+ Experience in biocompatibility is a must for the Principal level.
+ Experience with implantable medical devices is a plus.
+ Proficiency with Excel pivot tables, sterile processing, quality management systems, and design validation.
Work Environment
The role is based in medical device manufacturing for cardiovascular devices, with 90% of the time spent at the Lake Forest site and 10% at the San Clemente site.
The position involves collaborating with a team dedicated to developing innovative vascular intervention devices, including catheters and stents.
Job Type & Location
This is a Permanent position based out of Lake Forest and San Clemente, California.
Pay and Benefits
The pay range for this position is $140000.00 - $200000.00/yr.
Internal employee benefits include but are not limited to:MedicalDentalVisionPTO, Holiday CA Sick PayAdditional employee benefit options
Workplace Type
This is a fully onsite position in San Clemente,CA.
Application Deadline
This position is anticipated to close on Nov 3, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions.
We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market.
With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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Unlock Your Quality Engineer Potential: Insight & Career Growth Guide
Real-time Quality Engineer Jobs Trends in San Clemente, United States (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Quality Engineer in San Clemente, United States using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 179601 jobs in United States and 6377 jobs in San Clemente. This comprehensive analysis highlights market share and opportunities for professionals in Quality Engineer roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! Actalent is currently hiring and seeking a Quality Engineer to join their team. Feel free to download the job details.
Wait no longer! Are you also interested in exploring similar jobs? Search now: Quality Engineer Jobs San Clemente.
An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Actalent adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Quality Engineer Jobs United States varies, but the pay scale is rated "Standard" in San Clemente. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for Quality Engineer typically include Other General and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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Here are some tips to help you prepare for and ace your job interview:
Before the Interview:To prepare for your Quality Engineer interview at Actalent, research the company, understand the job requirements, and practice common interview questions.
Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the Actalent's products or services and be prepared to discuss how you can contribute to their success.
By following these tips, you can increase your chances of making a positive impression and landing the job!
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