Senior Quality Assurance Engineer - (Medical device exp is a must) Job at Suna Solutions, Riverside, CA

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  • Suna Solutions
  • Riverside, CA

Job Description

Job Posting: Senior Quality Assurance Engineer

Location: Riverside, CA 92503

Compensation: $110,000–$150,000 DOE + 10% Annual Bonus

Employment Type: Direct hire role

Drive Excellence in Quality and Compliance

Are you a seasoned Quality Engineer ready to make a significant impact in a dynamic manufacturing environment? We’re seeking a Senior Quality Assurance Engineer who brings technical expertise, regulatory insight, and a proactive mindset to our growing team in Riverside, CA. This is a critical role that blends strategic leadership with hands-on engineering, overseeing quality across supplier, customer, and production touchpoints.

What You’ll Do

In this position, you will represent the Quality Assurance and Regulatory Affairs function across a range of process and product initiatives. You’ll lead our Material Review Board (MRB) efforts, support internal auditing, drive supplier quality improvements, and help ensure compliance with key standards, including FDA 21 CFR 820, ISO 13485, ISO 9001, and EU MDR .

Key Responsibilities:

  • Lead MRB processes and manage nonconforming material through to resolution
  • Perform root cause investigations and implement effective corrective actions
  • Conduct and guide inspections of components, materials, and final products
  • Develop and maintain inspection plans using industry-standard tools and sampling methods
  • Act as the quality representative on design and development teams
  • Participate in internal audits and support compliance efforts for external audits
  • Collaborate cross-functionally to interpret technical and regulatory requirements
  • Train and mentor QC personnel in best practices for inspection and documentation
  • Support supplier qualification, risk management, and quality systems improvements

What We’re Looking For

Qualifications:

  • Bachelor’s degree in Mechanical Engineering, Quality Engineering, or related field, or equivalent experience
  • 5–10 years of experience in quality assurance or quality engineering, ideally in medical device, aerospace, or defense industries
  • Working knowledge of FDA 21 CFR 820, ISO 13485, ISO 9001, and related quality system standards
  • Experience in internal auditing is strongly preferred
  • Proficiency in ERP systems (e.g., EPICOR), Microsoft Office Suite, and statistical tools
  • Strong analytical, documentation, and communication skills
  • Medical device exp is a must

Preferred Skills:

  • Experience with metrology standards (e.g., ASME Y14.5), SPC, and problem-solving methodologies (8D, root cause analysis, etc.)
  • Familiarity with customer, supplier, and regulatory audits
  • Ability to read and interpret engineering drawings, technical manuals, and specifications

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 (888) 223-4788, 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.

Job Tags

Hourly pay, Work at office, Local area, Remote work,

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