R+D Quality Engineer III

Regulatory Jobs; Versailles (OH); On-site; USD 90,000 - 130,000; Full time

Job summary

Regulatory Jobs seeks an experienced R&D Quality Engineer III to lead and enforce product development quality initiatives for medical devices. You will drive regulatory compliance, risk management, and documentation across the NPD lifecycle.

Key focus areas include leading FMEA processes, applying Six Sigma methods, and mentoring junior engineers while collaborating with cross-functional teams to meet business goals.

Qualifications

• Bachelor's degree in engineering or related field with 4+ years of experience.
• CQE, Six Sigma Black Belt, and CRE certifications preferred.
• Experience in the medical device industry and quality systems knowledge desired.
• Proficiency with MS Word, PowerPoint, Excel, Project, and Minitab.

Responsibilities

• Plan, lead, and manage quality deliverables on new product development (NPD) projects per ISO 9001:2015, ISO 13485:2016 and FDA regulations.
• Lead risk management processes and create risk management documentation for NPD projects.
• Create, review and approve documentation for Product Realization Process (PRP) including change requests and design records.
• Facilitate design FMEA and process FMEA; act as SME for quality initiatives.
• Mentor I & II engineers and lead cross-functional quality improvements.

Skills

Quality assurance

Regulatory standards

Risk management

Six Sigma

Cross-functional teamwork

Mentoring

FMEA

Quality systems

Statistical tools

Education

Bachelor's degree in engineering

CQE certification

Six Sigma Black Belt (DMAIC, DMADV)

CRE certification

Tools

Minitab

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Project

Job description

JOB SUMMARY:

The R + D Quality Engineer III leads and enforces product development quality initiatives through identifying, investigating, planning, and conducting activities aimed at insuring robust and quality design and manufacturability of medical devices.

ESSENTIAL/PRIMARY DUTIES:

• Plans, leads, and manages quality deliverables on new product development (NPD) projects in accordance with regulatory standards ISO9001:2015, ISO13485:2016, ISO14971, FDA, CSA, and EU MDR regulations.
• Leads all risk management processes and creates risk management documentation for (NPD) projects.
• Creates, reviews, and approves documentation related to the engineering Product Realization Process (PRP). Documentation includes, but is not limited to, change requests, engineering orders, product and component test specifications and design records.
• Facilitates the design and process failure mode and effects analysis (FMEA) process.
• Leads site-based quality department initiatives as a subject matter expert (SME).
• Applies domain expertise to the application and advancement of engineering methods and tools. Leads the application of six sigma techniques and drives continuous process improvement.
• Collaborates with cross-functional teams to align decisions with business goals.
• Mentors engineer I & II teammates, focusing on technical skills, collaboration skills, and cultural competencies.
• Applies advanced tools and methods to solve complex problems. Tackles technical challenges and contributes to troubleshooting effort.

SECONDARY DUTIES:

• Supports internal and external quality system audits.
• Leads the creation of threat models and cybersecurity risk assessments.
• Leads the creation and maintenance of the products Usability Engineering Files, provides misuse cases involving use error and assesses the impact.
• Assists with the creation of the reliability predictions for projects with recommended testing profiles and analyzes test results.

EDUCATION and/or EXPERIENCE:

Bachelor's degree in engineering or related field and 4+ years of relevant experience, or equivalent combination of both. Certified Quality Engineer (CQE), Six Sigma Blackbelt (DMAIC, DMADV), and Certified Reliability Engineer (CRE) certifications preferred.

COMPETENCY and/or SKILL:

• Experience in the medical device industry and understanding of medical device quality systems and applications is desired.
• Mastery of software programs - Microsoft Word, PowerPoint, Excel, Project, Minitab
• Strong written and verbal communication skills
• Ability to apply advanced analytical tools and methods to solve complex problems
• Ability to lead the design of complex systems and identify new technological opportunities

SUPERVISORY RESPONSIBILITIES:

• Provides leadership, coaching, and/or mentoring to level I and level II engineers.