Staff Engineer I, Quality Systems

Jenavalve Technology Inc; Irvine (CA); On-site; USD 110,000 - 190,000; Full time

Job summary

Jenavalve Technology Inc. in Irvine, CA, seeks a Staff Engineer, Quality Systems to lead QA activities across the product lifecycle and ensure compliance with FDA and ISO standards.

You will drive CAPAs, NCRs, audits, and QMS improvements while collaborating with Regulatory, Manufacturing, and R&D teams. The role requires strong documentation, cross-functional communication, and hands-on participation in validation and change control.

Qualifications

• BS in Biomedical Engineering or equivalent; MS preferred.
• Minimum 5+ years in medical device or pharmaceutical industry.
• Experience in regulated manufacturing environments with 21 CFR Part 820, ISO 13485, ISO 14971.

Responsibilities

• Lead Quality System activities including CAPAs and NCRs.
• Support audits (FDA, Notified Bodies) and supplier audits.
• Drive QMS improvements and KPI harmonization across sites.
• Collaborate with Regulatory, Manufacturing and R&D teams.
• Support software validation and change control processes.

Skills

Quality Systems

CAPA

Audits

Documentation

Project Management

Cross-functional Collaboration

Communication

Education

Bachelor's in Biomedical Engineering

MS preferred

Tools

eQMS

Verification/Validation

Job description

Job Title: Staff Engineer, Quality SystemsStaff Engineer I, Quality SystemsStaff Engineer II, Quality SystemsStaff Engineer III, Quality SystemsRole Level: Individual ContributorSupervisor/Manager Title: Director, Global Quality and ComplianceJob Location & Environment: Irvine, CA – Corporate OfficeJob 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 globallySupport 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 initiativesProvide technical guidance to quality specialists and junior engineers supporting the various quality system elements.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 14971Skills 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 meetingsProven 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.