Senior Quality Systems Engineer

RASIRC

$100K — $130K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in chemistry, chemical or mechanical engineering
  • 6-10 years of experience in regulated manufacturing or quality environments
  • Experience with ISO 9001 quality systems
  • Preferred project or program coordination experience in technical environments
  • Working knowledge of audits, documentation control, and CAPA
  • Familiarity with semiconductor manufacturing processes
  • Strong organizational skills and ability to track multiple projects simultaneously

Responsibilities

  • Support and maintain the ISO 9001 Quality Management System
  • Execute quality system activities as per established procedures
  • Assist with audits and track findings for corrective actions
  • Maintain controlled documents and training documentation within the QMS
  • Support documentation accuracy and change requests
  • Assist with root cause analysis and CAPA activities
  • Coordinate with cross-functional teams to ensure quality compliance

Benefits

  • Comprehensive training program for career advancement
  • 77% employer coverage for designated health plan
  • Paid Time Off
  • 401k with company match
Full Job Description
RASIRC is seeking a detail-oriented Senior Quality Systems Engineer to support and maintain the company's Quality Management System and related quality processes. This role is an individual contributor position focused on execution, compliance, and system support within a regulated manufacturing environment.

This position is well suited for a professional with strong organizational skills who is effective at process execution, documentation, and cross-functional coordination.

Position Overview:

The Senior Quality Systems Engineer supports the operation and maintenance of RASIRC's Quality Management System (QMS) in alignment with ISO 9001 and applicable customer and regulatory requirements.

The Senior Quality Systems Engineer works under the direction of Quality leadership and collaborates with engineering, manufacturing, and supply chain teams to ensure quality system requirements are followed consistently.

Key Responsibilities:

Quality System Support
  • Support the maintenance and execution of the ISO 9001 Quality Management System.
  • Execute assigned quality system activities in accordance with established procedures.
  • Assist in preparation for internal, external, customer, and supplier audits.
  • Track audit findings and support closure of corrective actions as directed.

Documentation & Change Control
  • Maintain controlled documents, records, and training documentation within the QMS.
  • Support document revisions, change requests, and record updates.
  • Ensure documentation accuracy and compliance with quality system requirements.

CAPA & Nonconformance Support
  • Support root cause analysis and corrective and preventive action (CAPA) activities.
  • Track CAPA progress and verify completion and effectiveness under supervision.
  • Assist with investigation and documentation of nonconformances and deviations.

Project Coordination
  • Assist with coordination of assigned, limited-scope projects related to quality, manufacturing, or compliance.
  • Track action items, timelines, and deliverables for assigned initiatives.
  • Prepare status updates and communicate progress or risks to project owners or functional leads.
  • Support handoff and knowledge transfer activities as part of transition planning.

Cross-Functional Coordination
  • Coordinate with engineering, manufacturing, and supply chain teams to ensure quality requirements are followed.
  • Support quality-related activities for product development and manufacturing operations.
  • Provide routine status updates on assigned tasks and projects.

Metrics & Reporting
  • Collect and organize quality system metrics and project tracking data.
  • Maintain logs, trackers, and reports for audits, CAPAs, training, and assigned projects.


Qualifications:
  • Education: S. in chemistry, chemical or mechanical engineering
  • 6-10 years of experience in a regulated manufacturing, engineering, or quality environment.
  • Experience supporting ISO 9001 quality systems.
  • Prior exposure to project or program coordination in a technical environment is preferred.
  • Working knowledge of quality systems, audits, documentation control, and CAPA.
  • Familiarity with semiconductor manufacturing processes and regulated environments.
  • Strong organizational and tracking skills.
  • Clear written and verbal communication skills.
  • Comfortable executing assigned work under direction.
  • Ability to manage multiple tasks and limited-scope projects simultaneously.
  • Detail-oriented with a strong follow-through mindset.


Other Requirements
  • Citizenship: RASIRC does not assume the responsibility to sponsor employees; this job requires US citizenship or a Permanent Resident Certificate (Green Card).
  • Ability to stand for extended periods and perform repetitive tasks.
  • Ability to lift and move up to 35 pounds.
  • Must be willing and able to work in environments that require frequent bending, reaching, and lifting.
  • Use of personal protective equipment (PPE) as required. Ability to work in an ISO Class 6 cleanroom with required cleanroom garb.
  • This role requires working with dangerous and toxic liquids and gaseous chemicals and strictly following all safety protocols.


What We Offer:
  • The salary range for this position is $100,000 - $130,000/per year, depending on experience and qualifications.
  • RASIRC values employee growth and development and with that has a comprehensive training program to ensure that you reach the goals of your position, as well as provide the resources needed for your future career goals.
  • Health and Wellness Benefits: RASIRC pays 77% of the designated base plan with a multiple plan private exchange for employee health insurance for employees.
  • Paid Time Off
  • 401k with company match


How to Apply:

If you are ready to take on this exciting opportunity, please submit your resume and cover letter to https://rasirc.bamboohr.com/careers

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