Quality Engineer

Title: CAPA Quality Engineer

Pay: $90.00 -100.00

Hours: Monday–Friday | 8:00 AM–5:00 PM

Location: Murrysville, PA 15668 or Cambridge, MA (Hybrid)

Duration: 10 month contract

Overview

We are seeking a CAPA Quality Engineer to support corrective and preventive action (CAPA) activities within a regulated medical device environment. This role will lead complex investigations, drive root cause analysis, manage cross-functional CAPA projects, and ensure compliance with quality system requirements and regulatory standards.

The ideal candidate will have experience in Quality Engineering, CAPA management, root cause investigations, and medical device regulations, with the ability to influence stakeholders and manage multiple projects in a fast-paced environment.

Job Description

• Facilitate product and process CAPA investigations from issue identification through implementation and effectiveness monitoring
• Independently create, manage, and complete CAPA records and documentation
• Lead cross-functional teams through root cause analysis and corrective action implementation
• Project manage all CAPA activities, including timelines, resources, deliverables, and stakeholder communication
• Schedule and lead CAPA team meetings
• Present CAPA progress and outcomes during audits and CAPA Review Board meetings
• Analyze quality data and performance trends to identify actual and potential nonconformances
• Apply statistical techniques to support investigations and decision-making
• Review complex test data, product performance information, and investigation findings
• Lead quality problem-solving activities involving hardware and software-related issues
• Ensure compliance with applicable quality system regulations and standards
• Partner with management to secure resources and support for CAPA implementation plans
• Mentor team members on root cause analysis methodologies and quality investigation techniques
• Support initiatives related to CAPA program improvement and regulatory compliance

Required Skills

• Bachelor's degree in Mechanical Engineering, Electronics Engineering, Science, or related field
• 5 years of related engineering experience with a Bachelor's degree, or 3 years with a Master's degree
• Experience leading CAPA investigations and corrective action programs
• Strong root cause analysis and problem-solving skills
• Project management experience
• Knowledge of quality engineering principles and methodologies
• Experience analyzing data and applying statistical techniques
• Strong written and verbal communication skills
• Ability to influence and collaborate across multiple organizational levels
• Experience working in regulated environments

Preferred Skills

• Medical device industry experience
• Experience supporting FDA-regulated products
• Knowledge of Pride Problem Solving methodology
• Experience with software and hardware quality investigations
• Audit support experience
• CAPA Review Board participation experience

Regulatory Knowledge

• 21 CFR Part 803
• 21 CFR Part 806
• 21 CFR Part 820
• ISO 13485
• ISO 9001
• ISO 14971

Education Requirements

• Bachelor's Degree in Mechanical Engineering, Electronics Engineering, Science, or related discipline required
• Master's Degree preferred

Benefits (employee contribution):

Health insurance

Health savings account

Dental Insurance

Vision Insurance

Flexible spending accounts

Life insurance

Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.