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Quality Engineer

Precision Edge Surgical Products Company LLC

As a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway—you’ll be doing things that matter, leading at every level, and winning a better way. We’re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best.

Salary Position

Welcome to Precision Edge Surgical Products

Precision Edge is a world-renowned contract manufacturer of fine surgical components, cutting tools and accessories. As a surgical cutting tool manufacturer, we pride ourselves in our technical versatility and ability to assist our customers. We understand the fundamental requirement of superior performance from a surgical instrument and our team takes extreme pride in building quality products which provide a competitive edge for our customers.

Work With Us!

To make the best surgical instruments, we need the best people. We’re always looking to add talent to our team! As a colleague at Precision Edge, you’ll impact the health and wellbeing of thousands of orthopedic patients worldwide.

Quality Engineer: Quality is #1 and the Quality Engineers at Precision Edge Surgical make sure that happens every day. As a member of our Engineering team you’ll play a direct part in the project lifecycle of product creation, production timelines, and quality standards.

Some of the duties and responsibilities include: 

  • The development and execution of validation plans to support FDA, ISO and company standards.
  • Creating and managing project tasks and schedules to support overall production scheduling
  • Supporting supplier audits to insure capabilities and evaluate process change requests to align with both the company and customer requests.
  • Performing hazard and risk analysis for new legacy products
  • Linking the efforts and communications of both the quality and operations personnel to insure that inspection processes have been verified and documented.
  • Identifying new inspection equipment
  • Leading the root cause analysis for any internal product quality issues or customer complaints
  • Mentoring and training team members

Education/Experience

  • BS in Engineering required
  • ASQ Certified Quality Engineer certification (preferred)
  • Supervisor or leadership experience (preferred)

Essential Functions, Knowledge and Competencies

  • Thorough understanding of current ISO 13485 and FDA QSR (21 CFR Part 820) requirements and how they relate to our company
  • Advanced understanding of GD&T and metrology
  • Proficient in various software applications (i.e. Microsoft Office and Minitab preferred)
  • Must possess excellent documentation and technical writing capabilities
  • Independent self-starter who is capable of planning and managing multiple priorities
  • Ability to incorporate ASTM and ISO standards through the product life cycle, designing and developing the required inspection and process control methodologies
  • Must have excellent interpersonal skills, having the ability to interface with all levels of the organization, customers and suppliers
  • Thorough knowledge of analytical tools including Six Sigma, Lean and SPC
  • Ability to manage multiple projects simultaneously without supervision. This includes creating detailed and accurate project tasks and schedules, interfacing with internal and external customers and solving project related conflicts and issues
  • Strong supervisory and team building skills

We offer completive wages and amazing benefits, some of which are:

  • Benefits starting on DAY 1:
    • Health, dental, & vision insurance for employees, spouses and dependent children up to age 26
    • Company-paid short and long term disability coverage
    • Company-paid life and AD&D insurance
    • Voluntary life insurance for employee, spouse and dependent children up to age 18
    • Vacation pay that accrues on a bi-weekly basis
    • Paid Holidays

  • Benefits starting on the first of the month following 30 days of employment:
    • 401k retirement savings plan with a 50% company match up to a 3% match

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to careers@marmon.com, and please be sure to include the title and the location of the position for which you are applying.

Average salary estimate

$70000 / YEARLY (est.)
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$60000K
$80000K

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What You Should Know About Quality Engineer, Marmon Holdings, Inc.

We're excited to introduce an outstanding opportunity at Precision Edge Surgical Products Company LLC for the role of Quality Engineer! As part of the global industrial organization Marmon Holdings, you'll be stepping into a crucial position where you'll play a vital role in ensuring the top-notch quality of surgical components, cutting tools, and accessories that positively impact the lives of orthopedic patients worldwide. In this dynamic environment, you'll participate in the complete project lifecycle—developing and executing validation plans that align with FDA and ISO standards, creating project schedules to keep production on track, and supporting supplier audits to ensure top-quality manufacturing processes. Your expertise will also lead you to perform hazard and risk analyses on new and legacy products, facilitating effective communication between quality and operations teams to ensure all inspections meet rigorous standards. Plus, as a mentor, you'll help train and build the next generation of talent. If you're ready to dive into a workplace where everyone is empowered to make a meaningful impact, and you're keen on working with a team that values your skills and ideas, then Precision Edge Surgical Products is the perfect place for you!

Frequently Asked Questions (FAQs) for Quality Engineer Role at Marmon Holdings, Inc.
What responsibilities does a Quality Engineer have at Precision Edge Surgical Products?

A Quality Engineer at Precision Edge Surgical Products plays several critical roles, such as developing validation plans for compliance with FDA and ISO standards, managing project tasks to align with production schedules, and performing risk analyses on products. They also lead root cause analyses for product quality issues, support supplier audits, and ensure effective communication between quality and operations personnel.

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What qualifications are required for the Quality Engineer position at Precision Edge Surgical Products?

To be considered for the Quality Engineer role at Precision Edge Surgical Products, candidates should possess a BS in Engineering and ideally hold an ASQ Certified Quality Engineer certification. Leadership experience is also preferred. Additionally, candidates should have a strong understanding of ISO 13485 and FDA requirements, coupled with excellent documentation skills and proficiency in software applications.

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What kind of projects will a Quality Engineer work on at Precision Edge Surgical Products?

Quality Engineers at Precision Edge Surgical Products engage in diverse projects related to the lifecycle of surgical instruments. They are instrumental in creating and overseeing validation plans, conducting supplier audits, and performing hazard analyses, ensuring every phase of product development meets the highest quality standards.

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How does Precision Edge Surgical Products support professional development for Quality Engineers?

At Precision Edge Surgical Products, professional growth is a priority. Quality Engineers can expect opportunities for ongoing training and mentoring, where they’ll develop their abilities to tackle complex challenges, understand industry standards, and lead quality improvement initiatives within the company.

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What benefits do Quality Engineers receive at Precision Edge Surgical Products?

Quality Engineers at Precision Edge Surgical Products enjoy competitive wages and impressive benefits, which include health, dental, and vision insurance starting on Day 1, company-paid disability coverage, life insurance, a 401k retirement plan with company matching, and a generous vacation policy.

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Common Interview Questions for Quality Engineer
Can you explain your experience with ISO 13485 and FDA QSR standards as a Quality Engineer?

When answering this question, focus on how you've implemented ISO 13485 and FDA QSR standards in your previous roles. Mention specific projects, your role in developing processes that comply with these regulations, and any improvements you made based on audits or assessments.

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How do you approach risk analysis in product development?

To effectively answer this, describe your methodical approach to risk analysis, emphasizing your experience in hazard identification, risk assessment, and mitigation strategies. Provide an example where your analysis significantly improved the product outcome.

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Describe a time when you had to resolve a quality issue in production.

Use the STAR method to answer this question: describe the Situation, the Task you were responsible for, the Actions you took to resolve the issue, and the Result. Highlight your problem-solving approach and how you collaborated with team members to ensure quality.

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What tools do you use for statistical process control?

Discuss the statistical tools you are familiar with, such as Minitab or other SPC software. Detail how you’ve used these tools to interpret data and maintain quality standards in prior positions.

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How do you manage multiple projects simultaneously as a Quality Engineer?

Explain your project management techniques, such as prioritization, time management, and the tools you use (e.g., Gantt charts, task lists). Provide examples of how you successfully managed overlapping deadlines and project requirements.

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What strategies do you employ to mentor junior quality engineers?

Speak to your mentoring style, emphasizing your approach to providing feedback, sharing knowledge, and encouraging the professional growth of junior engineers. Mention specific success stories where your mentorship positively impacted their careers.

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Can you give an example of how you led a root cause analysis?

Provide a detailed account of a specific situation where you conducted a root cause analysis. Focus on the methods you used to identify the root cause, the team dynamics during the process, and the favorable results that followed.

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How do you stay updated with changes in quality standards and regulations?

Discuss the resources you utilize to keep current with industry standards, such as webinars, professional organizations, or publications. Highlight any relevant training or certifications you pursue to enhance your expertise.

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What experience do you have with supplier audits?

Detail your experience with conducting supplier audits, including how you prepare for audits, what criteria you evaluate, and how you've worked on improving supplier quality based on audit findings.

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In your opinion, what is the most challenging aspect of being a Quality Engineer?

Reflect on the challenges in the role, such as maintaining high standards under production pressures or navigating regulatory hurdles. Discuss how you proactively address these challenges and ensure quality is never compromised.

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With more than 120 autonomous manufacturing and service businesses, Marmon Holdings, Inc. is the biggest small business you’ll ever find. Part of Berkshire Hathaway Inc., Marmon is a global industrial organization comprising 11 industry groups wit...

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Full-time, on-site
DATE POSTED
March 31, 2025

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