Product Quality Engineer- Medical Device

Product Quality Engineer - Medical Device

This range is provided by Collabera. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$40.00/hr - $50.00/hr

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Position Overview

The Sr. Product Quality Engineer provides design quality expertise to product development teams, ensuring patient/user safety, customer satisfaction, and organizational success. This role involves leading risk management activities and supporting a broad range of development quality functions.

Key Responsibilities

• Lead and support on-time completion of Design Control deliverables
• Establish objective, measurable, and verifiable product requirements
• Plan and execute Design Verification and Validation, including investigations and resolution activities
• Lead risk management from product concept through commercialization
• Support test method development and validation
• Assist with manufacturing process development and qualification for new products and design changes
• Define component specifications, sampling plans, and vendor qualifications
• Support biocompatibility and sterilization qualifications
• Participate in audits and quality system improvement initiatives
• Support organizational initiatives in Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory compliance
• Maintain collaborative communication with all levels of employees, contractors, and suppliers

Basic Qualifications

• Bachelor’s degree in Engineering or related technical field
• Minimum 5 years of experience in R&D, process/manufacturing engineering, or quality, with at least 2 years in product development
• Experience in medical device regulations and standards
• Experience in test method development and validation
• Experience preparing risk assessments, FMEA, and other risk documentation

Preferred Qualifications

• Advanced degree in Engineering or technical field
• Experience with active implantable medical devices
• Familiarity with requirements management tools (e.g., DOORS) and problem reporting systems (e.g., JIRA)
• Working knowledge of statistics applied to verification and validation

Benefits

medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time, paid sick, and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually – These all are subject to applicable eligibility

Seniority Level

Mid-Senior level

Employment Type

Contract

Job Function

Engineering and Science

Industries

Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing

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