(Cloud) Manufacturing Quality Engineer

We have a contract opportunity for a "Cloud" Quality Engineer in Lake Forest California. This position is approved for 2 years supporting a Medical Device Manufacturer.

Pay Rate : $60.00 to $65.00 / Hr.

Summary :

The Quality Engineer is responsible for development, modification, application and maintenance of quality standards and processes applicable to Technical Services.

Collaborates with Technical Service, Field Service, Cloud Operations and Digital Health teams to ensure quality standards are in-place and applied in operational environments.

This position will primarily support company cloud products.

Job Description :

• Collaborates on development and refinement of Global Technical Service and Digital Health processes to streamline operations and enhance compliance and operational efficiencies.
• Ensures performance and quality of products conform to established standards and agency guidelines resulting in exceptional customer experience.
• ChaNpions Technical investigations of product and process quality issues.
• Ensures corrective measures comply with standards and support high-level product performance requirements.
• Leads development and provides guidance on equipment, process, and software verification and validation.
• Work closely with product development, cloud operations, and DevOps teams to ensure high-quality releases and seamless integration of new features.
• Develops methodology to measure compliance and quality metrics for Technical Service.
• Collaborates with Cloud Operations to develop and review operational change requests.
• Monitor and analyze key performance indicators (KPIs) related to quality performance and identifying opportunities for improvement.
• Leads development of post-market data and trending analysis for Digital Health and supports documentation related to product complaints.

Education and Required Experience :

• Bachelor's Degree in an Engineering, Computer Science, Mathematics, Physical Science discipline, or equivalent years of directly related experience.
• Minimum 3 years experience in Quality Operations / Manufacturing / Engineering / Field Service in relevant GMP industry.

Medical Device or Healthcare a plus.

• Experience with regulatory standards in medical device, including FDA, ISO 13485, IEC 62304, HIPAA and GDPR
• Experience with MS Office, Excel, PowerPoint, Visio, MS Teams, SharePoint, JIRA, MS Project.

A Plus (But Not Necessary) :

Knowledge of cloud platforms, cloud infrastructure management, change requests and software release deployment is a plus but not necessary.

Note : Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description.

All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.