Staff Engineer I, Quality Systems

JenaValve Technology, Inc.; Irvine (CA); Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

JenaValve Technology, Inc. in Irvine, CA is seeking a Staff Engineer, Quality Systems to lead quality system activities across product development and commercialization, ensuring compliance with FDA 21 CFR 820, ISO 13485, EU MDR, and MDSAP.

You will collaborate with Regulatory, Manufacturing Operations and R&D to drive CAPA, non-conformance, change control, audits, and quality metrics, and provide guidance on software validation and risk management.

Formación

• Bachelor's degree in Biomedical Engineering or related field; MS preferred.
• 5+ years in medical device or pharmaceutical quality environment.
• Experience with FDA 21 CFR Part 820 and ISO 13485; regulatory awareness.

Responsabilidades

• Collaborate with Regulatory, Manufacturing Ops and R&D to support QMS and core processes.
• Lead CAPAs, NCRs, MRB, internal audits and management reviews; drive improvements.
• Support FDA inspections, Notified Body audits, and supplier audits; close findings.
• Support software validation activities and related documentation and testing.
• Lead harmonization of quality KPIs across sites worldwide.
• Provide guidance on risk management and quality metrics trending.

Conocimientos

Quality Engineering

Regulatory knowledge

Cross-functional collaboration

Project management

Communication

Risk management

Analytical thinking

Educación

B.S. Biomedical Engineering

M.S. preferred

Herramientas

eQMS

CAPA software

Audit tools

Descripción del empleo

Job Title

Staff Engineer, Quality Systems

Staff Engineer Levels

• Staff Engineer I, Quality Systems
• Staff Engineer II, Quality Systems
• Staff Engineer III, Quality Systems

Role Level

Individual Contributor

Supervisor/Manager Title

Director, Global Quality and Compliance

Job Location & Environment

Irvine, CA – Corporate Office

Job Description Summary

Responsible for Quality Systems and Quality Engineering tasks associated with new product development and commercialization in compliance with global regulatory requirements and industry standards (FDA 21 CFR 820, ISO 13485, EU MDR, MDSAP) and alignment with business objectives. Support various QMS initiatives and processes, including CAPA, non-conformance, change control, management review, quality metrics, and inspection readiness.

Job Responsibilities

• Collaborate with cross-functional teams such as Regulatory, Manufacturing Operations, and R&D to support the Quality Management System and core processes, eQMS system enhancements and validation activities, and ensure QMS requirements are embedded through product lifecycle.
• Promote proactive quality culture and support training on quality system fundamentals and practices across Quality and cross-functional groups.
• Lead Quality System activities including CAPAs, Nonconformance Reports (NCRs), Material Review Board (MRB), internal audits, management reviews, and quality metrics trending to drive robust corrective and preventive actions.
• Support FDA inspections, Notified Body audits, supplier audits, and internal audits, including investigation and timely closure of audit findings.
• Support technology innovation and digital transformation initiatives by evaluating and implementing modern analytical tools, automation, and advance quality monitoring systems.
• Lead harmonization of quality KPIs across all sites globally
• Support software validation activities including, but not limited to, authoring relevant verification/validation documentation such as user/functional requirements specifications, vendor assessments, risk assessments, testing plans, protocols/scripts, and reports, executing verification/validation testing, and developing procedures related to specific software use.
• Support RGA process compliance including receipt, evaluation, investigation, and documentation of returned goods while ensuring appropriate linkage to complaints, traceability requirements, and QMS records are maintained.
• Act as SME for all quality system processes improvement initiatives
• Provide technical guidance to quality specialists and junior engineers supporting the various quality system elements.

Qualifications

Required Education and Experience

• Bachelor of Science degree in Biomedical Engineering, or equivalent engineering discipline required. Master of Science degree preferred.
• Quality Engineering experience in production and/or R&D support is required.
• Minimum of 5+ years of experience in the medical device or pharmaceutical industry is required.
• Direct experience in regulated manufacturing environment and knowledge of regulations and standards: 21 CFR Part 820, ISO 13485, ISO 14971

Skills And Abilities Required For This Job

• Must adhere to the company code of conduct and contribute to fostering a professional, collaborative, and respectful team working environment.
• Highly self-disciplined and proactively motivated. Capable of meeting goals with minimal supervision and managing multiple concurrent projects.
• Must be able to work effectively and collaborate within cross functional teams.
• Must be able to effectively articulate quality issues, investigation results, and conclusions, both verbally and in writing, to technical and non-technical personnel.
• Strong project management and documentation skills required.
• Must be able to take initiative and have the ability to perform hands-on work.
• Ability to manage multiple tasks with strong attention to detail.
• Strong presentation skills to represent Quality as a function during business meetings
• Proven risk management skills.

Physical Requirements

• Minimal travel (~10%) may be required for audit support activities.
• Must be able to follow cleanroom, including compliance with applicable gowning and PPE requirements, and site safety protocols at all times.