Quality Engineer II

What You'll Do:

As a Quality Engineer II, you'll be a key technical expert and quality champion across our organization. You'll take ownership of advanced quality assurance functions, lead complex investigations, drive continuous improvement, and ensure our systems exceed regulatory expectations. You'll collaborate across Engineering, Manufacturing, and Quality to keep our products safe, compliant, and high-performing-every time.

This is a high-impact role where your work directly influences patient outcomes, product reliability, and operational excellence.

Your Responsibilities Will Include:

Complaint Management & CAPA Leadership

Lead complaint investigations, determine regulatory reportability, and implement corrective and preventive actions.

Mentor teams on root cause analysis and drive effectiveness checks for CAPA closure.

Equipment & Process Qualification

Oversee calibration and preventive maintenance programs.

Support manufacturing engineering with qualification protocols (IQ/OQ/PQ), deviations, risk assessments, and change control activities.

Contribute to the Validation Master Plan and ensure all qualification documentation is audit-ready.

Supplier & Quality System Support

Conduct supplier audits and evaluate supplier performance.

Support internal/external audits (FDA, ISO, MDSAP) and monitor key quality metrics.

Product Acceptance & Nonconformance Management

Oversee incoming, in-process, and final inspections.

Analyze inspection data, investigate nonconformances, and drive timely resolutions.

Lead MRB meetings and ensure NCRs are thoroughly documented and closed.

Manufacturing Process Controls

Ensure cleanroom compliance, monitor bioburden/particulate results, and review sterility testing.

Collaborate with Manufacturing to reduce scrap and rework while improving yield.

Maintain controlled documentation and support ongoing operator training.

Deviation Management

Ensure complete documentation and timely closure of deviations.

Assess impact on quality, safety, and compliance while coordinating cross-functional responses.

What You Bring

Bachelor's degree in Engineering or a related field (preferred).

Experience in quality engineering within medical devices, manufacturing, or healthcare environments.

Strong knowledge of ISO 13485, FDA regulations, CGMP, and quality system methodologies.

Excellent communication skills and the ability to work collaboratively across teams.

Strong analytical mindset and the ability to interpret complex technical data.

Proficiency with Microsoft Office and quality tools.

Why You'll Love Working at Cork Medical

At Cork Medical, you'll join a collaborative, mission-driven team where your ideas matter and your work truly saves lives. You'll gain exposure to every part of our operations, elevate your expertise, and contribute to solutions that help patients heal faster and stronger.

We invest in our people-if you're passionate about growth, problem-solving, and contributing to innovation in medical technology, this is a place where you can thrive.

Physical Requirements

Ability to sit for extended periods while working at a computer.

Ability to lift up to 15 pounds occasionally.

Equal Opportunity Employer

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