Sr. Development Quality Engineer

Spectraforce Technologies; Pleasanton (CA); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Sr. Development Quality Engineer to enhance product development through design quality expertise. This role involves leading risk management activities, ensuring compliance with regulatory standards, and supporting test method validation. Collaborating with cross-functional teams, you'll contribute to patient safety and customer satisfaction while driving quality management initiatives. Join a forward-thinking organization committed to innovation in the medical device sector, where your expertise will make a significant impact on product quality and safety.

Qualifications

• 5+ years of experience in R&D, Process/Manufacturing Engineering, and/or Quality.
• Experience in medical devices and associated regulations/standards.

Responsibilities

• Lead and support Design Control deliverables and Risk Management activities.
• Support test method development and manufacturing process qualification.

Skills

Design Control

Risk Management

Test Method Development

Quality Management Systems (QMS)

Regulatory Compliance

Education

Bachelor's degree in Engineering or Technical Field

Advanced Degree in Engineering/Technical Field

Tools

DOORS

JIRA

Job description

Title: Sr. Development Quality Engineer

Location: Pleasanton, CA, USA, 94588

Duartion: 6 months

Shift: 8:00AM to 4:00PM

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 product 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 Abbott, 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.

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"