We are currently seeking a Quality Engineer, with the below qualifications:
Professional Attributes
The Quality Engineer is responsible for ensuring that products, processes, and systems
meet internal quality standards, customer requirements, and applicable regulatory
guidelines. This role focuses on validation planning, inspection control, metrology systems,
and cross-functional quality support. The Quality Engineer also serves as the main quality
point of contact for customer concerns and is responsible for leading the review and
disposition of Non-Conforming Material Reports (NCMRs). The position supports product
integrity, regulatory compliance, and continuous improvement across the manufacturing
operation.
Desired Skills and Experience
1. Validation Planning & Execution
• Develop, review, and execute equipment, process, and product validation
protocols including IQ (Installation Qualification), OQ (Operational
Qualification), and PQ (Performance Qualification).
• Define and manage validation master plans, validation schedules, and test
methods in alignment with engineering and regulatory requirements.
• Coordinate with cross-functional teams to validate new tooling, equipment,
product designs, and process changes.
• Document and maintain all validation records, traceability matrices, and
summary reports in accordance with the company's Quality Management
System (QMS).
2. Inspection Planning & Execution
• Design and implement effective inspection strategies for incoming materials,
in-process production, and final product release.
• Create and maintain inspection criteria, control plans, and visual aids based
on product specifications and engineering drawings (including GD&T).
• Conduct First Article Inspections (FAI), capability studies, and inspection
audits to ensure compliance with defined quality standards.
• Train inspectors and production personnel on proper inspection procedures
and defect identification.
3. Metrology & Measurement Systems
• Oversee calibration and maintenance of all measurement and inspection
equipment, ensuring traceability to national/international standards.
• Conduct Measurement Systems Analysis (MSA), including Gage
Repeatability & Reproducibility (Gage R&R), to validate the reliability of
measurement tools.
• Recommend and implement metrology best practices, including appropriate
inspection techniques for complex geometries and tolerances.
4. NCMR Review & Disposition
• Review and evaluate Non-Conforming Material Reports (NCMRs) from
production, inspection, or incoming material.
• Lead disposition decisions (use-as-is, rework, return to vendor, or scrap) in
collaboration with Engineering, Manufacturing, and Supply Chain.
• Document actions taken and ensure appropriate containment and corrective
actions are implemented.
5. Customer Interface & Communication
• Act as the main point of contact for customer quality concerns, audits, and
issue resolution.
• Respond to customer complaints and initiate root cause analysis and
corrective actions (8D, 5 Why, Fishbone, etc.).
• Provide timely updates and reports to customers regarding product quality,
non-conformance investigations, and corrective actions.
6. Quality Assurance & Compliance
• Ensure compliance with internal procedures, customer-specific requirements,
and industry standards (ISO 9001, ISO 13485, IATF 16949, etc.).
• Participate in internal and external quality audits and support audit
preparedness and corrective actions.
• Maintain documentation such as non-conformance reports (NCRs), deviation
records, and change control documentation.
7. Problem Solving & Continuous Improvement
• Lead or support root cause investigations and the implementation of
Corrective and Preventive Actions (CAPA) using structured problem-solving
tools such as 8D, 5 Why, and Fishbone Analysis.
• Collaborate with engineering, manufacturing, and supply chain to reduce
scrap, rework, and customer complaints.
• Participate in Lean, Six Sigma, and Kaizen initiatives to optimize process
capability and efficiency.
8. Data Analysis & Reporting
• Collect, analyze, and present quality data including inspection results,
validation outcomes, calibration status, and nonconformance trends.
• Generate monthly/quarterly quality performance reports for internal reviews
and customer reporting.
• Utilize statistical tools (SPC, Minitab, Excel, etc.) to interpret data and drive
decisions.
9. Supplier Quality (as needed)
• Support supplier qualification processes, including review of supplier
validation and inspection plans.
• Evaluate supplier performance through incoming inspection results and
nonconformance trends.
• Work with suppliers to address quality issues and support improvement
actions.
10.Other Duties as Assigned
• Take on additional responsibilities as needed to support the team and meet operational
priorities.
Specific Skill Set
Communication Strong verbal and written communication skills to
interface with teams and customers.
Presentation Excellent analytical skills to identify root causes and
recommend corrective actions.
System Proficient in quality management systems (QMS), ERP
systems, and Microsoft Office Suite.
Analytics Familiar with statistical tools (SPC, MSA), FMEA, control
plans, and Six Sigma methodologies.
Exposure
• Bachelor's degree in engineering (Mechanical, Industrial, Manufacturing, or
equivalent)
• 3-5 years of experience in quality engineering in a manufacturing environment
• In-depth knowledge of validation methodologies (IQ/OQ/PQ), inspection
planning, and metrology systems
• Proficiency in interpreting technical drawings, GD&T, and control plans
• Experience in using quality tools and statistical analysis techniques (SPC, MSA,
FMEA, Gage R&R)
• Working knowledge of ISO 9001, ISO 13485, IATF 16949, or other relevant
standards
• Strong written and verbal communication skills
• Experience with quality software tools (e.g., Minitab, QMS platforms) is a plus
WORK ENVIRONMENT
The work environment is usually in an office within a manufacturing facility with low to
moderate noise level. The work environment characteristics described here are
e of those an employee encounters while performing the essential functions of
this job.
• Ability to work well with others, one on one, remote, via video and phone.
• Ability to work independently
What You'll Love About Us:
- Salary: $120,000 (Based on education and experience)
- 11 Paid Holidays, Sick Pay, Vacation Pay
- 401K, Plus Employer Match
- Medical, Dental, Vision, Company Sponsored Life and AD&D, Short and Long Term Disability, Paid Parental Leave, and More...
