Quality Engineer – Medical Devices

Pyramid Consulting, Inc; El Paso (TX); On-site; USD 69,000 - 83,000; Full time

Benefits offered by this job

Health insurance

Job summary

Pyramid Consulting, Inc. is seeking a Quality Engineer for a Medical Devices project in El Paso, TX. This 04+ months contract role focuses on supplier quality management, audits, and regulatory compliance in a GMP environment.

Responsibilities include leading CAPA/SCAR activities, risk assessments, and cross-functional collaboration with procurement, manufacturing, and engineering teams to ensure FDA and ISO requirements are met. Bilingual English/Spanish preferred.

Qualifications

• Bachelor's degree in Engineering or related field.
• 5 years of Supplier Quality and/or Supplier Development experience.
• Knowledge of 21 CFR 820, ISO 13485, ISO 14971.
• GMP regulated environment experience preferred.
• Bilingual English/Spanish communication skills.

Responsibilities

• Lead supplier quality management and risk assessment activities.
• Oversee supplier audits and ensure regulatory compliance.
• Drive CAPA/SCAR activities and corrective actions.
• Coordinate change notifications and supplier qualification projects.
• Collaborate with cross-functional teams to resolve quality issues.

Skills

Supplier Quality

Regulatory Compliance

CAPA/SCAR

Auditing

Data Analysis

Cross-functional Collaboration

Education

Bachelor's degree in Engineering

Tools

GMP Auditing

Quality Management Systems

Job description

Immediate need for a talented Quality Engineer – Medical Devices. This is a 04+months contract opportunity with long-term potential and is located in El Paso, TX(Onsite).

Job ID: 26-28726

Pay Range: $50/hr - $60/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision).

Key Responsibilities:

• Supplier Quality Management
• Collaborate with suppliers and internal business partners to ensure robust materials, products, processes, and quality systems.
• Manage supplier quality performance through data analysis, trend monitoring, and risk assessment activities.
• Identify supplier quality risks and drive mitigation plans to minimize business disruptions.
• Develop and maintain Supplier Quality Agreements in collaboration with suppliers and Supplier Quality leadership.
• Lead supplier performance improvement initiatives and supplier development activities.
• Supplier Audits and Compliance
• Plan, execute, document, and follow up on supplier quality system audits.
• Evaluate supplier compliance with FDA regulations, ISO standards, and client Quality System requirements.
• Assess supplier quality systems and manufacturing controls to ensure continued compliance.
• Support supplier qualification and requalification activities.
• Investigations and Corrective Actions
• Lead and support supplier-related root cause investigations.
• Drive supplier Corrective and Preventive Actions (CAPA) and Supplier Corrective Action Requests (SCARs).
• Ensure effective implementation and verification of corrective actions.
• Escalate critical supplier quality issues when intervention is required.
• Change Management
• Manage supplier change notifications and change control activities.
• Coordinate impact assessments for supplier and material changes.
• Support supplier transitions, component qualifications, and validation activities.
• Partner with cross-functional teams to ensure timely approval and implementation of changes.
• Lead supplier quality improvement projects with minimal supervision.
• Apply Lean, Six Sigma, and Performance Excellence tools to improve supplier performance and process capability.
• Utilize methodologies such as: DMAIC, Kaizen, Value Stream Mapping (VSM), Failure Mode and Effects Analysis (FMEA), Root Cause Analysis (RCA), Measurement System Analysis (MSA), Statistical Process Control (SPC), Capability Analysis (Cp/Cpk/Ppk), Design of Experiments (DOE)
• Cross-Functional Collaboration
• Partner with Procurement, Manufacturing, Operations, Engineering, Technical Operations, and R&D teams to investigate and resolve supplier-related quality issues.
• Support new product introduction (NPI) and component qualification projects.
• Participate in risk management and product improvement efforts.
• Communicate supplier quality issues, trends, and opportunities to management.
• Quality and Regulatory Compliance
• Ensure compliance with: FDA 21 CFR Part 820, ISO 13485, ISO 14971, client's Quality System Requirements, Environmental, Health & Safety policies
• Support FDA inspections and external regulatory audits.
• Maintain accurate documentation in accordance with ALCOA+ principles and good documentation practices.

Key Requirements and Technology Experience:

• Bachelor's degree in Engineering or related field.
• 5 years Supplier Quality and/or Supplier Development
• Understanding of 21 CFR 820, ISO 13485, and ISO 14971 requirements
• Prior Supplier Quality experience in a manufacturing plant or technical background
• Working experience in good manufacturing practice regulated environment is preferred (medical device, pharmaceutical, etc.)
• Bilingual professional with strong verbal and written communication skills in both English and Spanish.
• Demonstrated knowledge of manufacturing principles and practices, and procedures
• Direct experience in plant and/or supplier GMP auditing
• Broad experience with quality systems, including but not limited to validation, non-conformance, CAPA/SCAR systems and investigations, production and process controls
• Experience with documentation and technical writing skills, in a regulated compliance environment
• Demonstrated ability to identify compliance risks and assess business impact
• Ability to manage complexity and lead critical discussions
• Ability to deal with complex issues using deductive reasoning, critical analysis skills and systematic approaches
• Strong analytical and problem-solving abilities.
• Ability to assess compliance risks and business impact.
• Excellent project management and organizational skills.
• Ability to manage complexity and influence cross-functional teams.
• Strong verbal and written communication skills.
• Ability to lead critical discussions with suppliers and business leaders.
• Proficient in Microsoft Office applications and quality management systems.

Our client is a leading Medical Device Equipment industry, and we are currently interviewing to fill this and other similar contract positions.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.