Summary: Seeking a Quality Engineer with expertise in quality management systems and regulatory requirements for the Medical Devices and Pharmaceutical industries.

Requirements:

Bachelor's degree Minimum of 2 years professional experience in Medical Devices, Pharmaceutical, or regulated industry Strong knowledge of ISO 13485, FDA QSR

Preferred Skills:

Expertise in validation and CAPA processes

Responsibilities:

Approve IQ, OQ, PQ Champion compliance with global regulations and standards Conduct investigations and manage non-conformances, CAPAs, and customer complaints Analyze effectiveness of preventive and corrective actions Review root cause investigations Maintain quality metrics and indicators Serve as Subject Matter Expert (SME) Develop validation strategies Partner with supply chain for process validation and risk management Conduct analytical/statistical analysis for process improvements

Pay Details: $45.00 to $55.00 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 ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan Francisco Fair Chance Ordinance