Quality Engineer III

Technical Recruiter for Engineering Division;
Life Sciences, Med Device, Pharma, Aerospace and Manufacturing Working direct hire roles and contract… Quality Engineer III – Field CAPA & Design Quality Additional Information

• Pay Rate: $64/hr
• Schedule: 8:00 AM – 4:30 PM
• Contract to Perm

The Quality Engineer III will serve as a key leader within the Field CAPA and Design Quality team, driving cross‑functional investigations to identify actionable root causes and implement effective solutions for high‑visibility product performance issues. This role supports Active Implantable & Accessories products within the Cardiac Rhythm Management and Diagnostics (CRMDx) division.

This position is ideal for a technically strong individual with natural curiosity, a passion for complex problem‑solving, and an interest in leadership and project management. The engineer will collaborate closely with Research & Development, Regulatory, Marketing, Medical Safety, Manufacturing, Post Market, and other Quality organizations. Additional responsibilities include supporting Design Quality initiatives in risk management, new product development, and product sustainment.

• Lead cross‑functional teams on complex product performance investigations where product design is the suspected root cause, including NCEPs, CAPAs, and Field Action recommendations.
• Drive collaborative problem‑solving using structured methodologies such as DMAIC, Root Cause Analysis, 5 Whys, Cause & Effect Diagrams, and Is/Is Not analysis.
• Build, maintain, and strengthen cross‑functional partnerships across multiple sites; provide guidance on technical strategies and issue resolution.
• Represent the team in global and divisional leadership forums.
• Create and maintain detailed investigation documentation in accordance with Good Documentation Practices.
• Create, review, and approve Quality System records for NCEPs and CAPAs.
• Present investigation updates in both formal and informal settings, including to senior leadership.
• Mentor and guide engineers and cross‑functional teams on NCEP and CAPA execution, potentially across multiple divisions.
• Champion continuous improvement initiatives within local and divisional Design Assurance organizations.
• Promote a diverse and inclusive work environment that enables all contributors to reach their full potential.
• Ensure compliance with company policies, procedures, and Quality System requirements.
• Demonstrate a strong commitment to patient safety and product quality.

• Build quality into all aspects of work by maintaining compliance with all quality requirements.
• Adhere to the Quality Policy and all documented quality processes and procedures.

• Bachelor’s degree in engineering or a related discipline, plus 4+ years of relevant experience.
• Knowledge of Quality System Regulations, Medical Device Regulation, and ISO 13485.
• Experience in the medical device industry.
• Experience with non‑conforming products/processes, CAPAs, Field Action decision‑making, and investigation processes.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook).

• Experience with active implantable medical technologies.
• Strong technical problem‑solving and data analysis skills.
• Experience with statistical tools (e.g., MINITAB, Weibull++).
• Ability to multi‑task effectively and adapt to changing priorities.
• Strong business acumen and communication skills, with the ability to articulate impact and consequences.
• Ability to collaborate and influence across diverse, cross‑functional teams.
• Experience leading multiple projects across engineering disciplines (Software, Hardware, Labeling, etc.).
• Self‑starter with a track record of identifying improvement opportunities.
• Comfortable presenting to groups, including senior divisional leadership.