Quality Systems Specialist - Entegee

Job Summary:
Oversee quality programs, systems, processes, and procedures within a medical device organization, ensuring compliance with regulatory standards and leading audit and inspection preparation.

Job Requirements:

• BS in Engineering

• 5+ years of experience in quality systems within the medical device industry

• Experience with CAPA root cause analysis and action planning

• Familiarity with 21CFR820 and ISO13485

• Experience with Agile MAP and TrackWise software

• Demonstrated problem-solving skills

• Strong technical writing abilities

Preferred Skills:

• Certified Quality Auditor certification

• Project management experience

• Exposure to design and development processes

• Familiarity with quality systems documentation

Job Responsibilities:

• Work with CAPA and NCR owners across the organization to execute the CAPA process in a compliant and timely manner

• Lead audit and inspection preparation, including the resolution of findings and coordination with auditors and inspectors

• Provide oversight for the development and maintenance of quality programs, ensuring compliance with policies and regulatory standards

• Offer expertise and guidance in interpreting and applying governmental regulations and industry guidelines

• Coordinate legal requests to support government investigations or litigations

Pay: 36-48
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: $36.00 to $48.00 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