Sr. Quality Engineer

30+ days ago

Job Description

Job Description:

We are seeking an experienced Sr. Quality Engineer with strong expertise in Medical Device Quality and Regulatory Compliance. The ideal candidate will have hands-on experience in quality systems, risk management, complaint handling, post-market surveillance, and regulatory compliance within the medical device industry.
This role will support product development, manufacturing, and quality assurance activities to ensure compliance with industry regulations and standards.

Responsibilities:

Lead design transfer and production support activities while ensuring compliance with FDA and ISO 13485 requirements.
Support manufacturing readiness and quality initiatives across product development programs.
Manage quality activities for assigned product components/subassemblies to ensure design integrity and manufacturability.
Investigate non-conformances using root cause analysis and drive CAPA activities within the Quality Management System.
Develop and maintain FMEAs, support risk mitigation efforts, and lead issue resolution activities.
Support qualification activities including IQ/OQ/PQ.
Identify and implement compliant solutions for engineering and production challenges.
Maintain and improve Quality Management System (QMS) processes.
Collaborate with cross-functional teams including Engineering, Manufacturing, Operations, and Quality.
Interpret and apply medical device regulations and quality standards throughout the product lifecycle.
Support internal, external, and regulatory audits and ensure timely closure of audit findings.

Requirements:

Bachelor's degree in mechanical engineering or a related field.
ASQ CQE certification is preferred.
Minimum 6 years of experience in the Medical Device industry.
Strong understanding of Medical Device Quality Systems and regulatory requirements.
Hands-on experience with ISO 13485:2016/2019 and 21 CFR Part 820.
Experience in Complaint Handling and Post Market Surveillance (PMS) activities.
Knowledge of global Medical Device Regulations including MDD/MDR.
Experience managing Non-Conformance (NC) processes, CAPA, and internal/external audits.
Strong background in Medical Device Risk Management (ISO 14971).
Experience with Application, Process, Design, and System FMEA methodologies.
Proficiency in statistical tools and techniques, including Design of Experiments (DOE).
Ability to perform descriptive and non-parametric statistical analyses.
Experience using advanced statistical methods for reliability analysis and data-driven decision making.

Preferred Skills:

Experience working in highly regulated environments.
Strong problem-solving and analytical skills.
Excellent communication and stakeholder management abilities.
Ability to manage multiple projects and priorities simultaneously.
Experience working with cross-functional teams in a fast-paced environment.
Keywords:
Medical Device, ISO 13485, FDA, 21 CFR Part 820, CAPA, NC, Complaint Handling, Post Market Surveillance, PMS, MDR, MDD, Risk Management, ISO 14971, FMEA, DOE, QMS, IQ/OQ/PQ, Regulatory Compliance, Quality Engineer, Medical Device Quality.

Location

Santa Clara, CA

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