Quality Engineer

Responsible for maintaining and improving Quality Management Systems (QMS) for Class III implantable medical devices, ensuring compliance with regulatory standards and supporting cross-functional teams.

---

Job Requirements:

• 2-5 years of experience as a Quality Engineer in the medical device industry.
• Experience with Class III/implantable medical devices.
• Experience maintaining and working within an ISO 13485 Quality Management System (QMS).
• Familiarity with regulatory standards including ISO 13485, MDR, and FDA requirements.
• Experience with the CAPA process and managing QMS documents and systems.
• CE Marking experience.

---

Preferred Skills:

• Experience supporting cross-functional teams across Engineering and Quality departments.
• Knowledge of QMS tools and document control systems.
• Ability to interpret and apply global regulatory standards to ensure compliance.

---

Job Responsibilities:

• Maintain and improve Quality Management System (QMS) in compliance with ISO 13485, MDR, and FDA regulations.
• Manage CAPA processes to ensure timely identification, correction, and prevention of quality issues.
• Ensure documentation and QMS records are maintained accurately and in compliance with regulatory requirements.
• Support CE Marking processes and documentation for Class III medical devices.
• Collaborate cross-functionally with Engineering and Quality teams to drive product quality improvements.
• Provide guidance on regulatory compliance and QMS best practices to internal teams.
• Assist in internal and external audits to ensure compliance with applicable standards.

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