Quality Engineer

Rheo Engineering LLC is seeking a Quality Engineer to be the driving force behind excellence.

About the Role:
The ideal candidate will thrive in a collaborative environment, identify and resolve quality issues, drive continuous improvement, and ensure our processes meet the highest standards.

Main Responsibilities:

• Own and manage corrective and preventive action (CAPA) activities.
• Identify trends in quality issues and proactively address recurring or systemic problems.
• Collaborate with applicable stakeholders to resolve design, manufacturing, and supplier quality issues.
• Support engineering change requests (ECRs) and operations change management by assessing quality impacts and ensuring quality requirements are met.
• Participate in product reviews, design-for-quality activities, and process validations as needed.
• Develop, update, and verify effectiveness of inspection plans, sampling criteria, and quality checklists.
• Support Quality Control and Production teams by clarifying inspection requirements and contributing to first-article inspections.
• Manage the tool calibration program to ensure all equipment and instruments are maintained in compliance with internal procedures and industry standards.
• Maintain quality documentation related to investigations, inspections, validations, changes, and calibration.
• Assist in maintaining ISO 9001 certification and supporting compliance with applicable industry standards and customer requirements.
• Provide quality support for customer complaints, including root cause analysis, communication, and corrective action tracking.

Success in this Role Looks Like:
- Corrective actions are implemented quickly and effectively with minimal recurrence.
- Collaboration with other departments leads to early detection and resolution of quality risks.
- Inspection and calibration plans are complete, clear, and effective in preventing defects.
- Continuous improvement efforts result in measurable reductions in defects, rework, and customer complaints.

Requirements:

• Bachelors degree in engineering or a related technical field with 3 years of quality or engineering experience OR 5 years of relevant experience in a quality-focused role in a manufacturing or technical environment.
• Familiarity with ISO 9001 and/or FDA standards and other relevant quality standards.
• Strong proficiency in Microsoft Office programs (Word, Excel, PowerPoint, Outlook, Teams).
• Experience with Quality Management Systems (QMS) and ERP systems (Epicor Kinetic preferred).
• Strong problem-solving and analytical skills.
• Excellent communication and cross-functional collaboration abilities.
• Attention to detail and a methodical, documentation-oriented approach.
• Proactive mindset with a passion for continuous improvement and risk reduction.

Preferred Qualifications:

• Experience conducting or supporting internal audits.
• Background in regulated manufacturing (pharmaceutical, medical device, or biotech).
• Familiarity with Lean, Six Sigma, or other process improvement methodologies.

Working Conditions:
This role requires the ability to work in both office and manufacturing environments. Must be able to navigate the shop floor, participate in hands-on investigations, and lift up to 50 pounds when necessary. Up to 10% travel.

Benefits:

• Leading Medical Insurance consistently the leading medical rates for small businesses in the area
• Health Savings Account with Employer contributions (depends on plan selected)
• Dental Insurance
• Vision Insurance
• Life Insurance
• Identity Theft Insurance
• 401k with 4% employer match
• Generous PTO
• Paid Paternity & Maternity leave
• Paid cell phone plan with stipend for new phone every 2 years
• Referral program

Compensation details: $70,000 - $85,000 Yearly Salary

Salary : $70,000 - $85,000