Quality Engineer

Innova Solutions is immediately hiring for a Quality Engineer
Position type: Full-time Contract
Duration: 9 months
Location: San Diego, CA
As a Quality Engineer you will:
Job Summary:
As a successful Quality Engineer you will provide Quality compliance support for the following Quality tasks and duties. Support the transfer of products and processes to a new manufacturing site. Review installation, operation and performance validation protocols and reports to ensure compliance to procedures and policies. FDA and ISO 13485 (and other applicable standards) requirements.
In this job, you will:

• Reviews protocols and reports to ensure compliance to procedures and policies, FDA and ISO 13485 requirements.
• Assist manufacturing engineers to establish statistically based sampling plans for validation and verification protocols.
• Develops, reviews, and approves validations and completion reports for existing products, processes and equipment. Provides statistical analysis of the data to support the reports.
• Ensures that all projects follow GLP, QSR (including Design Controls), ISO or other applicable requirements.
• Formulates detailed product quality plans based on results of risk analysis.
• Supports the Quality Management Review Process as required.
• Identifies opportunities for continuous improvement.
• Interacts and coordinates activities with other departments.
• Works with manufacturing engineering transfer team to ensure all aspects of product and process transfer activities are being met.
• Assists or leads in the prompt implementation of Non-Conformance resolution, and Corrective & Preventative Action(s) (CAPA support) as required.
• Performs other Quality Systems related duties as required.
  Qualifications:
• Bachelor's degree from college or university in an engineering or scientific discipline with minimum 4 years related Quality Assurance Engineering experience in the medical device industry. Equivalent combination of education and experience may be considered.
• Possess a good working knowledge of regulatory expectations and industry practices including industry standards QSR, ISO13485, MDD, MDR, CMDR, JPAL
  • Excellent organizational; problem solving; decision-making; communication (oral and written); and influencing skills.

Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.
Thank you!
Preeti Sehgal
preeti.sehgal@innovasolutions.com
PAY RANGE AND BENEFITS:
Pay Range*: $40 - $55/hr
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.
Recent Recognitions:

• One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
• ClearlyRated® Client Diamond Award Winner (2020)
• One of the Largest Certified MBE Companies in the NMSDC Network (2022)
• Advanced Tier Services partner with AWS and Gold with MS

Website: https://www.innovasolutions.com/
Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.
The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.