Quality Engineer II

sgs-job-4108

Engineering
 California
validation
quality engineering
process validation
equipment qualification
PFMEA
risk assessment
change control
GMP
ISO 13485
21 CFR Part 820
statistical analysis
documentation (protocols & reports)

Contract - 06 Months

Location : San Diego, CA 92121 Quality Engineer II is responsible for supporting validation activities, risk management, and quality system compliance in a regulated medical device environment. The role involves authoring and reviewing validation protocols, performing risk assessments, supporting change control, and ensuring compliance with GMP, ISO, and FDA requirements.

Job Responsibilities:

  • • Author and execute validation protocols and reports for equipment, processes, cleaning, analytical methods, facilities, and utilities • Develop and maintain master validation plans and validation strategies based on risk-based approaches • Perform process risk assessments including PFMEA, Non-Conformance Events (NCEs), and planned deviations (PDVs) • Review and assess change controls for validation impact and compliance requirements • Support equipment, process, and facility qualification activities in accordance with GMP and regulatory standards • Participate in new product introduction (NPI) and sustaining engineering projects • Collaborate with cross-functional teams including Manufacturing, Operations, and Regulatory Affairs • Support Material Review Board (MRB) and Production Response Team (PRT) activities • Ensure compliance with 21 CFR Part 820, ISO 13485, ISO 14971, and 21 CFR Part 11 requirements • Maintain validation records, documentation, and quality system deliverables • Support statistical analysis, acceptance sampling, and process capability studies • Provide status updates, escalate risks, and support continuous improvement initiatives • Assist in development and updates of quality procedures and controlled documents

Skills:

  • 3+ years (minimum 2+ acceptable) of experience in Quality Engineering within medical device, biotech, diagnostics, or pharmaceutical industry
  • Strong experience in validation (process, equipment, cleaning, analytical, facilities/utilities)
  • Hands-on experience authoring validation protocols and reports
  • Strong knowledge of PFMEA, risk assessment, and change control processes
  • Understanding of GMP, FDA regulations, ISO 13485, ISO 14971, and 21 CFR Part 820
  • Experience working with electronic document management systems
  • Strong analytical and problem-solving skills with attention to detail
  • Proficiency in MS Word, Excel, and Project
  • Strong communication and cross-functional collaboration skills

Education/Experience:

  • bachelor’s degree in science or engineering required

Related Jobs

Electronics Technician II

Engineering
 Texas
Red Oak, TX

Location - Red Oak, TX Hands-on support of commissioning activities under direct supervision, focused on electrical power and control systems within prefabricated modular data center products.

Electrical Testing
UPS

Downstream Planner

Engineering
 Texas
6 Months

Location - El Paso, TX Responsible for material replenishment (raw material and/or finished goods). Use MRP (right balance of Resource Vs Demand) to ensure stock availability on time at right place Collaborate with Upstream and Downstream Planning Leader and Supply and Inventory Planner

MRP
ERP
SAP
Supplier Management
Procurement

Database Engineer

Engineering
 Massachusetts
$41.00
6 Months

Location - Boston, MA The role involves close collaboration with Business and Technical Platform Product Owner (mainly Resolver), RLM program team as well as key stakeholders across Client Digital and Data & Performance teams, Data Domains, and E2E Data Flow Architects

SQL
ETL
Python GRC

Structured Contracts Specialist

Engineering
 Texas
6 Months

Location - El Paso, TX

Production
Manufacturing
Quality

Quality Auditor & Inspector

Engineering
 Massachusetts
$37.00
6 Months

Location - Foxboro, MA This position works in conjunction with Quality Assurance, Customer Service, Engineering, and our Product Expertise Centers globally, in the areas of quality evaluations, product audits and resolution of non-conforming materials. This position requires accuracy in recording results and the keeping of detailed records. Timely attention to submissions of returned exhibits to Expertise Centers is essential, as well as effective communication of findings, questioning of results and the providing of the information to others, including Customers, is imperative. Must be capable and effective in report preparation, data presentation, and reporting of technical and quality issues.

Inspection
Audit
QA

CX Lead, Digital Customer Experience (UI Designer/Developer)

Engineering
 North Carolina
3 Months

Location - Raleigh, NC The CX Lead is a key role on the North America Digital Customer Experience (NAM DCX) team, reporting directly to the Director of NAM DCX. This position is responsible for translating the regional digital experience strategy into high-impact, well-executed experiences that improve customer engagement, satisfaction, and business outcomes. Working in close partnership with the Director, global Digital teams, and regional Marketing, Sales, and business stakeholders, the CX Lead drives day-to-day execution, optimization, and continuous improvement across Client’s digital customer journeys. The role plays a critical part in ensuring experiences across web, eCommerce, and digital tools are seamless, customer-centric, data-informed, and aligned to NAM priorities. The ideal candidate is highly collaborative, detail-oriented, and customer-obsessed, with a strong ability to manage complex initiatives while balancing operational excellence with experience innovation

CX
UX
Digital Experience

Quality Auditor

Engineering
 California
$25.00
3 Months

Location - Costa Mesa, CA The Quality Auditor is responsible for ensuring that products, processes, and outbound shipments meet quality standards and customer requirements. This role supports quality activities across warehousing and logistics operations, panelboard manufacturing, and the production line responsible for equipment dismantling and rework activities The Quality Auditor performs in-process inspections, final product audits, shipping validations, and process compliance reviews while partnering with Operations, Manufacturing, Engineering, Continuous Improvement, and Supply Chain teams to drive quality excellence

Inspection
Auditing
QA

Site Safety & Health Officer

Engineering
 California
$26.00
6 Months

Location - Fort Irwin, CA The Quality Control Officer / Site Safety & Health Officer (QC/SSHO) is responsible for ensuring that all construction activities comply with contract requirements, applicable codes, project specifications, quality standards, and safety regulations. This position oversees project quality control processes and implements the site safety program to ensure work is completed safely, efficiently, and in accordance with approved plans and procedures. Responsibilities commonly include administration of the Quality Control Plan, Accident Prevention Plan (APP), inspections, documentation, corrective actions, and regulatory compliance.

EHS
Safety
Solar
EV

Engineer II

Engineering
 California
$58.00
2+ year

Location - San Clemente, CA Prepare or assist in the preparation of engineering designs, specifications, standards, studies, cost estimates and the development of sound technical recommendations, in support of projects and tasks managed by others within the Company electric utility departments. Apply a high level of technical expertise to solve engineering and operational problems. Coordinate and direct small projects and tasks, including development of work scope, budget, and schedule. Direct and assist team members, both Company employees and outside contractors, in the completion of their work. Coordinate input from, and participation with, various departments within the Company as needed to meet project objectives. Day to Day: Evaluate high SAIDI/CAIDI circuits to identify and develop reliability improvement projects that enhance distribution service reliability. Prepare and present project proposals to the reliability team. Candidates should have knowledge of power system studies and electrical distribution systems, as well as the ability to communicate complex electrical concepts effectively to customers

Power Distribution
feeders
transformers
protection
voltage
loading
distribution-system
SAIDI/CAIDI
outage causes
and Engineering Design
logo

At SGS Consulting, we go beyond resume-job matches, creating meaningful connections and pathways for individuals to thrive in defining careers.


© 2026 All rights reserved.
logologologologo