Sr. Quality Engineer- NPI

Verathon Inc; Tallassee, Duluth (AL, MN); On-site; USD 90,000 - 120,000; Full time

Job summary

Neptune Technology Group Inc. is seeking a Senior Quality Engineer for New Product Introduction to guide quality planning and risk management during development and launch.

You will collaborate with engineering, manufacturing, and supply chain to ensure products meet regulatory and customer requirements. The role requires a strong background in quality systems (ISO 9001/13485), DFMEA/PFMEA, and stage-gate development processes, with leadership and mentoring responsibilities for junior team

Qualifications

• Bachelor's degree or higher in Engineering, Quality Management, or related field.
• 5+ years of experience in quality engineering with focus on new product introduction.
• CQE certification is desirable.
• Strong knowledge of quality systems and standards (ISO 9001, ISO 13485).

Responsibilities

• Lead quality planning for new product introductions across design, manufacturing, and customer specs.
• Perform risk assessments and implement mitigation strategies.
• Identify and implement process improvements to enhance quality and efficiency.
• Provide direction and approval for critical reviews (Design Inputs, Design Verification & Validation, Technical & Design Reviews, manufacturing readiness, Risk Management).
• Lead DFMEA/PFMEA and Control Plan activities to reduce product risk.
• Collaborate with engineering, manufacturing, supply chain to mitigate risks during development.
• Provide training and mentorship to junior quality engineers.

Skills

Quality systems

Risk management

Leadership

Communication

Statistical analysis

GD&T

APQP

PPAP

Stage-gate process

Education

Bachelor's degree in Engineering or related field

Tools

DFMEA

PFMEA

APQP

PPAP

GD&T

Job description

The Senior Quality Engineer NPI (New Product Introduction) will play a critical role in ensuring the quality and reliability of new products during the development and launch phases. This position requires deep expertise in quality engineering, process validation, and cross-functional collaboration to drive successful product introductions while meeting regulatory and customer requirements.

Objectives

• Lead quality planning for new product introductions, ensuring alignment with design, manufacturing, and customer specifications.
• Risk Management: Conduct risk assessments and implement mitigation strategies to address potential quality issues during the product development lifecycle.
• Process Improvement: Identify and implement process improvements to enhance product quality and manufacturing efficiency.
• Provide direction and approval for critical reviews for Design Inputs, Design verification and Validation, Technical and Design Reviews, manufacturing readiness and Risk Management
• Champion and participate in the running and creation of DFMEA/PFMEA/Control Plan activities to eliminate or reduce product risk
• Collaborate with cross-functional teams (engineering, manufacturing, supply chain) to identify and mitigate quality risks during product development.
• Training and Mentorship: Provide training and mentorship to junior quality engineers and other team members on quality engineering principles and practices.

Qualifications

• Bachelor’s degree in Engineering, Quality Management, or a related field.
• 5+ years of experience in quality engineering, with a focus on new product introduction.
• Certifications: Certified Quality Engineer (CQE) or similar certification is highly desirable.
• Skills:
  • Strong knowledge of quality systems and standards (e.g., ISO 9001, ISO 13485).
  • Proficiency in risk management tools and methodologies (e.g., DFMEA, PFMEA)
  • Experience with GD&T, APQP, PPAP, Statistical Analysis
  • Excellent problem-solving and analytical skills.
  • Strong leadership and project management abilities.
  • Excellent communication and interpersonal skills to collaborate with cross-functional teams and external stakeholders.
  • Experience with a stage-gate product development process
  • Ability to work independently and manage multiple projects in a fast-paced environment.

Location

Tallassee, Alabama or Duluth, Georgia

Neptune Technology Group Inc. does not sponsor U.S. work authorizations for this position, including H-1B, O-1, and TN. Neptune also does not sponsor individuals in F-1 status for this role.

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