Job Title:

Senior Quality Engineer (6mo. Contract)

Job Type:

Contractor - 40 hours a week

Department:

Quality Assurance Hourly Rate:

$45 - $85

Location:

San Diego, CA Duration:

6-month contract Position Summary Supports design control, verification/validation, and risk management activities for medical device products in compliance with

FDA 21 CFR

Part 820/QMSR, ISO 13485, and

ISO 14971.

Serves as a technical quality resource across product development, manufacturing, and regulatory functions. Key Responsibilities Plan and execute design verification and validation testing per approved protocols (ISO 13485, FDA 820.30). Develop and maintain risk management files (FMEA, hazard analysis) per

ISO 14971.

Author and review test protocols/reports, specifications, and DHF/DMR records. Lead or support CAPA investigations, root cause analysis, and effectiveness verification. Serve as quality SME during internal audits and FDA/Notified Body inspections. Support supplier evaluation and validation activities and help maintain Approved Vendor List (AVL) per

ISO 13485.

Collaborate with R D, manufacturing, and regulatory affairs to resolve quality issues. Track and report quality metrics (NCR trends, CAPA closure rate, test turnaround). Perform other duties as needed. Minimum Qualifications Bachelor's degree in Engineering, Life Sciences, or related technical field. 5+ years of quality engineering experience in the medical device industry. Hands-on experience with design verification/validation testing and statistical methods (sampling plans, Gauge R&R). Strong knowledge of

FDA 21 CFR

Part 820/QMSR, ISO 13485, and

ISO 14971.

Preferred Qualifications ASQ CQE or CQA certification. Experience supporting 510(k) or EU MDR submissions. Familiarity with complaint handling and Class II implantable/catheter-based devices. Skills & Competencies Strong technical writing skills; proficient in MS Office and statistical/analysis tools. Detail-oriented with strong organizational, communication, and time management skills. Collaborative and solutions-oriented; able to work cross-functionally and influence without authority.

Pay:

$7,800.00 - $14,733.00 per month

Work Location:

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Senior Quality Engineer (6mo. Contract)