Sr Systems Quality Engineer - Entegee

Seeking a Senior Systems Quality Engineer with expertise in systems engineering methodologies, risk management, and regulatory compliance to support New Product Development (NPD) in the medical device industry.

Job Requirements:

• BS in Engineering

• 8+ years of experience in systems engineering, quality assurance, and regulatory compliance

• Experience with risk management, ISO 14971, and FDA/ISO standards

• Medical device industry experience

• Six Sigma Green Belt certification preferred

Job Responsibilities:

• Lead and mentor teams in quality assurance processes, collaborating with cross-functional teams including R&D, manufacturing, NPD, and regulatory affairs

• Conduct risk assessments, manage risk mitigation activities, and ensure compliance with FDA, ISO, and other international standards

• Oversee validation and verification activities, including test plan development and execution

• Ensure accurate documentation of quality assurance activities and regulatory compliance

• Define and manage systems requirements, ensuring alignment with customer needs and traceability

• Develop Critical to Quality (CTQ) matrices to identify key product characteristics and ensure regulatory compliance

• Lead project teams in testing clinician requirements, including the development and execution of design validation protocols

Risk Management Responsibilities:

• Develop and manage risk management plans, conduct hazard analysis, and perform Failure Modes and Effects Analysis (FMEAs)

• Analyze product complaints and implement preventive measures

• Collaborate on risk reviews, risk documentation, and post-market surveillance plans to monitor product performance

• Ensure product security measures are implemented to mitigate potential vulnerabilities
  
  

Pay:40-60

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.

Pay Details: $40.00 to $60.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance