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Senior Engineer, Supplier Quality

QUALIFICATIONS:

 

 

Required:

  • Bachelor's degree or higher in Mechanical Engineering, Biomedical Engineering, or related field from an accredited university.
  • A minimum of 6 years of relevant experience; OR master’s degree in related field plus 4 years’ experience

 

Preferred:

  • ASQ Certified Quality Engineer (CQE), ASQ Certified Quality Auditor (CQA)

 

Skills & Competencies:

  • Proficiency in MSA principles, Geometric Dimensioning and Tolerancing (GD&T), methods of risk-management, Minitab statistical software, tolerance stack analysis, process and manufacturing controls, software quality concepts, CAPA, non-conformances, post-market surveillance, Microsoft Office tools.
  • Strong analytical and creative problem-solving skills.
  • Excellent verbal communication and technical writing skills.
  • Possesses working knowledge in FDA, CE Regulatory, and New Product Design processes.
  • Demonstrates technical coaching and leadership of peers.

 

Physical Requirements:

  • Must be able to remain in a stationary position for extended periods of time
  • Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.
  • Ability to move about inside the office to access file cabinets, office machinery, etc

 

 

 

RESPONSIBILITIES:

  • Manage supplier quality documents and conduct periodic reviews.
  • Conduct periodic onsite and remote audits of critical suppliers.
  • Manage supplier corrective action activities and completion of reports.
  • Communicate with Supplier Quality Leaders on quality performance and areas for improvement.
  • Support the data collection and analysis for Supplier Performance Scorecards.
  • Approve new suppliers.
  • Facilitate qualification of components including writing validation protocols and reports for component qualifications as needed.
  • Ensure accurate and controlled supplier quality documents are generated.
  • Drive improvements utilizing Lean methodologies using supplier scorecards and rankings.
  • Coordinate inspection fixture procurement and integration of fixtures at the supplier.
  • Troubleshoot material non-conformances with suppliers.
  • Contribute to supplier continuous improvement activities.
  • Develop and support strong collaborative relationships with external design/development, manufacturing partners and suppliers.

Average salary estimate

$100000 / YEARLY (est.)
min
max
$80000K
$120000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Senior Engineer, Supplier Quality, Enable Injections Inc.

Join our team as a Senior Engineer, Supplier Quality at our vibrant Cincinnati, Ohio location! In this pivotal role, you will oversee and enhance the quality processes associated with our suppliers, ensuring that our products meet exceptional standards. As a Senior Engineer, you'll leverage your Bachelor’s or Master’s degree in Mechanical or Biomedical Engineering and at least six years of relevant experience to manage supplier quality documents, conduct audits, and lead corrective actions. Your expertise in MSA principles, GD&T, and statistical software like Minitab will be crucial as you analyze supplier performance via insightful data collection. You will communicate regularly with Supplier Quality Leaders, aiming for continuous improvement and ensuring compliance with all relevant regulations, including FDA and CE. Your leadership will be key, not only in troubleshooting non-conformances but also in fostering collaborative relationships with partners to cultivate quality throughout the supply chain. If you're ready to make a meaningful impact in a dynamic environment and continuously drive quality enhancements, we’d love to hear from you!

Frequently Asked Questions (FAQs) for Senior Engineer, Supplier Quality Role at Enable Injections Inc.
What are the main responsibilities of a Senior Engineer, Supplier Quality at the company?

As a Senior Engineer, Supplier Quality, your main responsibilities include managing supplier quality documents, conducting both onsite and remote audits of critical suppliers, and overseeing supplier corrective actions. You'll also support data collection for Supplier Performance Scorecards and facilitate the qualification of components by creating validation protocols and reports. Effective communication with Supplier Quality Leaders about performance and improvement areas is a key aspect of your role, along with driving improvements utilizing Lean methodologies.

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What qualifications are required for the Senior Engineer, Supplier Quality position?

To qualify for the Senior Engineer, Supplier Quality position, candidates must hold a Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field, combined with at least six years of relevant experience. Alternatively, a Master’s degree in a related field accompanied by four years of experience is acceptable. Preferred qualifications include certifications such as ASQ Certified Quality Engineer (CQE) or ASQ Certified Quality Auditor (CQA), which enhance your candidacy for this role.

Join Rise to see the full answer
What skills are essential for a Senior Engineer, Supplier Quality?

Essential skills for the Senior Engineer, Supplier Quality include proficiency in MSA principles, Geometric Dimensioning and Tolerancing (GD&T), and knowledge of risk management methods. Familiarity with Minitab statistical software, tolerance stack analysis, and quality concepts such as CAPA and non-conformances are also critical. Strong analytical and creative problem-solving skills, as well as excellent verbal communication and technical writing abilities, will be vital for success in this role.

Join Rise to see the full answer
How does the Senior Engineer, Supplier Quality contribute to supplier improvement activities?

The Senior Engineer, Supplier Quality contributes to supplier improvement activities by managing supplier performance scorecards, driving process enhancements through Lean methodologies, and facilitating collaborations that promote quality standards. By conducting audits and assessing corrective actions, you help create a culture of continuous improvement among suppliers, ensuring that they meet or exceed the established quality benchmarks.

Join Rise to see the full answer
What are the physical requirements for the Senior Engineer, Supplier Quality position?

Physical requirements for the Senior Engineer, Supplier Quality position include the ability to remain in a stationary position for extended periods and operate computer and office equipment consistently. Additionally, candidates should be able to maneuver around the office to access file cabinets and other necessary equipment, ensuring they can perform their functions effectively while managing supplier quality processes.

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Common Interview Questions for Senior Engineer, Supplier Quality
Can you describe your experience with managing supplier quality documents?

When answering this question, focus on specific examples where you've successfully managed supplier quality documents. Discuss the types of documents you've handled, how you ensure accuracy and compliance, and your methods for conducting reviews or audits of these documents.

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What methods do you use for conducting supplier audits?

In your answer, explain your approach to supplier audits, including preparation steps, criteria you assess, and how you document findings. Highlight the importance of communication during and after audits to foster supplier relationships.

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How do you handle non-conformances identified with suppliers?

To respond, describe your process for addressing non-conformances, including how to communicate the issues with suppliers, the steps you take in corrective actions, and how you monitor to ensure the implementations of those actions are effective.

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What experience do you have with statistical analysis tools in quality engineering?

When answering, include your familiarity with tools like Minitab, emphasizing specific projects where statistical analysis was crucial. Explain how your analysis influenced decision-making processes concerning supplier quality.

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Describe a successful project where you improved supplier quality.

Share a specific example of a project that led to quality improvement with a supplier. Discuss your role, the challenges faced, the steps you took, and the quantifiable results achieved as a result of your interventions.

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How do you ensure regulatory compliance in supplier quality processes?

Explain your understanding of relevant regulations regarding supply chain compliance, highlighting techniques you use to keep suppliers informed and involved in maintaining compliance standards.

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What strategies do you employ for effective communication with suppliers?

Discuss your communication style and methods. Stress the importance of transparency and regular check-ins to build strong partnerships with suppliers and ensure quality alignment.

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Can you explain your approach to data collection for supplier performance?

Outline the types of data you collect, the tools you use for analysis, and how you transform data into actionable insights to drive supplier quality improvements.

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What Lean methodologies have you applied in supplier quality management?

Provide specific examples where you've applied Lean principles. Discuss outcomes such as cost savings, improved efficiency, or enhanced quality resulting from your strategies.

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How do you prioritize tasks when managing multiple suppliers?

Describe your prioritization process, including how you assess urgency and impact on overall quality. Offer insights into how you balance competing demands to ensure effective supplier quality management.

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EMPLOYMENT TYPE
Full-time, on-site
DATE POSTED
April 9, 2025

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