Position: Quality Engineer
Location: Chatsworth, California 91311
Pay Rate: $38-$48/hour (W2)
Duration: 12-months Contract
Potential for Conversion: Yes, based on performance and business needs
About the Role
We are seeking a highly experienced and hands-on Quality Engineer to join our team in Chatsworth, CA. This is a contract position designed to cover two concurrent paternity leaves over the next 12 months. While the role is currently contract-only, there is potential for full-time conversion depending on business needs and individual performance.
We are not looking for entry-level candidates or recent graduates. Instead, we need someone who brings proven, real-world experience in ISO 13485 and medical device quality systems, and who can immediately contribute without a training ramp-up.
Key Responsibilities
- Design, implement, and maintain quality assurance protocols and systems.
- Ensure compliance with ISO 13485, MDSAP, and internal standards.
- Conduct detailed inspections, audits, and evaluations of production processes and outputs.
- Analyze quality data and trends to recommend process improvements.
- Lead and facilitate root cause investigations and CAPA initiatives.
- Collaborate cross-functionally to ensure quality objectives are met.
- Document and report quality issues, ensuring proper resolution and follow-up.
- Contribute to project planning, internal audits, and preparation for external inspections (notably, the ISO audit in October).
Required Qualifications
- Strong, hands-on experience in a regulated quality environment, ideally in medical devices.
- Solid working knowledge of ISO 13485 and quality system requirements.
- Demonstrated ability to support audits and implement continuous improvement practices.
- Experience leading investigations and driving corrective actions to closure.
- Must be eligible to work in the U.S. without current or future sponsorship.
Preferred Qualifications
- Bachelor's degree in Engineering or related technical field.
- 2+ years of relevant experience in quality assurance or manufacturing quality.
- Completion of CSUN's master's program in manufacturing and/or Green Belt certification is a strong plus.
EQUAL EMPLOYMENT OPPORTUNITY STATEMENT:
Suna Solutions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Applicants, with criminal histories, are considered in a manner that is consistent with local, state, and federal laws.
REQUESTING AN ACCOMODATION
Suna Solutions is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Suna Solutions and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.
If you would like to be considered for employment opportunities with Suna Solutions and have accommodation needs for a disability or religious observance, please call us at 1 , send us an email or speak with your recruiter.
PAY TRANSPARENCY POLICY STATEMENT
Compensation for roles at Suna Solutions varies depending on a wide array of factors including but not limited to the specific client, office or remote location, role, skill set and level of experience. As required by local law, Suna Solutions provides a reasonable pay scale to include the hourly or salary range that Suna Solutions reasonably expects to pay for roles that may be hired in California, Colorado, New York City or Washington as set forth below.