Senior Quality Engineer

TalentBurst, an Inc 5000 company; Irvine (CA); On-site; USD 61,992 - 82,656; Full time

Job summary

A leading provider in medical equipment is seeking a Senior Quality Engineer to implement and optimize quality practices related to complaints investigations. The role requires 5-7 years of experience, strong skills in documentation and communication, and knowledge of FDA regulations. This is a mid-senior level contract position in Irvine, CA, with an hourly pay range of $45.00 to $60.00.

Qualifications

• 5-7 years of experience in quality engineering or related fields.
• Ability to work in a fast-paced, team-oriented environment.
• Strong analytical and problem-solving skills.

Responsibilities

• Investigate quality and compliance issues in manufacturing.
• Lead Post Market Surveillance activities for EU-approved products.
• Ensure timely completion of complaint investigations and compliance.

Skills

Proven expertise in MS Office Suite

Strong documentation and communication skills

Basic understanding of statistical techniques

Attention to detail

Knowledge of FDA regulations

Leadership skills

Job description

Senior Quality Engineer (Complaint Investigation)

Location: Irvine, CA (100% Onsite)

Duration: 12+ Months Contract

Pay Range: $45.00/hr - $60.00/hr

Job Description

The main function of a Sr Engineer in this quality role is to focus on implementing and optimizing quality engineering practices related to Complaints Investigation, Post Market Surveillance and Risk Management while ensuring a culture of quality and compliance with global regulatory requirements.

Education and Experience

• 5-7 years of experience required.

Skills

• Proven expertise in the usage of MS Office Suite including MS Project; Electronic Quality Management System. Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
• Basic understanding of statistical techniques
• Team player and detail-oriented.
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Strong problem-solving, organizational, analytical and critical thinking skills
• Substantial understanding of processes and equipment used in assigned work
• Good leadership skills and ability to influence change
• Knowledge of applicable FDA regulations for the medical device industry
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment
• Must be able to work in a team environment, including inter‑departmental teams and key contacts representing the organization on contracts or projects
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/control

Job Responsibilities

• Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) based on engineering principles; analyze results, make recommendations and develop reports.
• Execute complaint investigations multifunctional approach and address issues addressed in a systematic, methodical manner.
• Lead Post Market Surveillance activities for products approved in the EU.
• Oversight of all complaints that require investigation through the different phases.
• Ensure on-time completion of complaints.
• Work closely with complaint investigation owners to resolve issues and ensure those that have passed their due dates are addressed.
• Ensure complaint investigations are adequate and comply with applicable procedures.
• Develop, update, and maintain technical content of risk management files
• Other incidental duties assigned by Leadership

Seniority Level

Mid-Senior level

Employment Type

Contract

Industry

Medical Equipment Manufacturing