Quality Engineer

Quality Engineer – Sage Product Development, Inc.

Apply now to join Sage Product Development, Inc. as a Quality Engineer. Our focus is on creating fast, efficient, and innovative medical device solutions for startups and established companies alike.

Benefits

• 401(k) plan
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off

Company Overview

Sage Product Development, Inc. is a lean, experienced medical device engineering team that delivers design, development, and manufacturing services with a client‑centric, problem‑solving approach. Our mission is to meet client challenges efficiently while maintaining highly personalized support.

General Summary

• Ensure ongoing compliance with quality standards.
• Establish and maintain low‑volume medical device manufacturing capabilities.
• Contribute product‑development expertise to project teams.

Essential Job Functions Quality Systems

• Develop and maintain quality assurance procedures to meet industry and regulatory standards.
• Ensure compliance with ISO 13485:2016 and 21 CFR part 820.
• Manage internal audit processes and coordinate external audit services.
• Approve Document Change Orders (DCOs) and obtain necessary approvals.
• Oversee calibration, preventive maintenance, complaints, CAPA, training, NCMR, and process deviation systems.
• Perform pest‑control monitoring and process improvement.

Manufacturing

• Provide quality oversight and review manufacturing documentation such as routings, inspection reports, and NCMRs.
• Manage supplier qualification, performance tracking, and NCMR disposition.
• Inspect components, assemblies, and finished goods and maintain inspection equipment.
• Maintain cleanroom conditions, microbial monitoring, and annual certification.
• Ensure packaging and labeling meet regulatory and customer requirements.
• Manage sterilization validation with external vendors.

Product Development

• Provide quality engineering expertise on projects to develop disposable and reusable medical devices, catheters, equipment, implants, and packaging.
• Ensure products meet performance specifications, regulatory, and manufacturing requirements.
• Serve as a professional interface with client companies, communicating proactively.
• Participate in verification and validation testing, data analysis, and risk analyses (FMEA, hazard analysis, risk management plans).
• Contribute to documentation such as design input, verification and validation plans, protocols, and reports.

Travel & Other Duties

• Occasional local travel by car; occasional long‑distance travel by plane.
• Perform any other duties as assigned.

Required Competencies Customer Focus

• Deliver reliable, prompt service to clients and coworkers, exceeding expectations.
• Interpret and respond to customer needs professionally and promptly.

Management of Resources

• Organize work efficiently, prioritize tasks, seek resources, and demonstrate initiative.

Communication Skills

• Write and speak concisely, clearly, and professionally.
• Maintain strong verbal presentation, negotiation, and active listening skills.

Qualifications

• Bachelor’s degree in Engineering or related science required; master’s degree in engineering, management, or business a plus.
• One or more years of medical device quality engineering experience required.
• Commitment to quality and regulatory compliance while promoting operational efficiency.
• Proficient in Excel, Word, PowerPoint, and other commonly used software.
• Knowledge of probability and statistics.
• Flexible, persistent, resourceful, and entrepreneurial.

Supervisory Responsibility

• May direct work of others and have direct reports.

Reports To

• Director of Quality

Working Conditions / Physical Demands

• Regular office and laboratory activity; requires lifting > 50 pounds and standing for extended periods.
• Exposure to laboratory chemicals tolerated.
• All duties may require reasonable accommodations for employees with disabilities.

#J-18808-Ljbffr