Sr. Quality Development Engineer

SPECTRAFORCE; Pleasanton (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading healthcare company in Pleasanton is seeking a Sr. Quality Development Engineer for a 6-month contract. This role involves providing quality expertise, supporting product development, and ensuring compliance with FDA regulations. The ideal candidate has 5+ years in R&D or Quality, preferably in medical devices, and strong experience in test method development and risk management. This position offers an opportunity to collaborate closely with various teams to contribute to product safety and quality.

Qualifications

• Minimum of 5 years of experience in R&D, Process/Manufacturing Engineering, and/or Quality.
• Experience in preparing risk assessments, FMEA, and other risk documents.
• 3 – 5 years of medical device (non-software) experience.

Responsibilities

• Lead and/or support on-time completion of Design Control deliverables.
• Support the establishment of objective, measurable, and verifiable product requirements.
• Comply with the client’s U.S. FDA, EUMDR, and other requirements.

Skills

Experience in medical devices

Test method development

Risk management

Education

Bachelor’s degree in Engineering or Technical Field

Advanced Degree in Engineering/Technical Field

Tools

JIRA

Requirements management tools (e.g., DOORS)

Job description

Job Title: Sr. Quality Development Engineer

Job Duration: 6 months

Job Location: Pleasanton, CA 94588

Description

The Sr. Development Quality Engineer will serve as a technical representative providing design quality expertise to a product development team. Responsible for maintaining a strong collaborative partnership with cross-functional team members to achieve patient/user safety, customer satisfaction, and organizational success.

Responsibilities

• Lead and/or support on-time completion of Design Control deliverables
• Support the establishment of objective, measurable, and verifiable product requirements
• Support Design Verification and Validation planning & execution, including any cross-functional investigation & resolution activities
• Lead Risk Management activities from product concept through commercialization
• Support test method development and lead test method validation activities
• Support manufacturing process development & qualification for new products and design changes
• Support the establishment of component specification definitions, supplied component sampling plan development, and vendor qualifications
• Support biocompatibility and sterilization qualifications
• Support audits and quality system improvement activities
• Support Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.
• Comply with the client’s U.S. FDA, EUMDR, and other requirements, as applicable.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers.

Basic Qualifications

• Bachelor’s degree in Engineering or Technical Field.
• Minimum of 5 years of experience in R&D, Process/Manufacturing Engineering, and/or Quality with at least 2 years supporting product development.
• Experience in medical devices and associated regulations/standards.
• Experience in test method development and validation
• Experience in preparing risk assessments, FMEA, and other risk documents.
• Looking for quality experience in med device. 3 – 5 years of medical device (non-software) experience, ideally in development quality, ideally with experience in risk management.

Preferred Qualifications

• Advanced Degree in Engineering/Technical Field
• Experience in active implantable medical devices.
• Knowledge of requirements management tools (e.g., DOORS) and use of problem reporting systems (e.g., JIRA).
• Working knowledge of statistics and its application to verification and validation?