Quality Engineer I

Precision Edge Surgical Products Company LLC

Come join a team where People make the difference! As a part of Marmon Holdings, Inc., a highly decentralized organization, we rely heavily on people with the aptitude, attitude, and entrepreneurial spirit to drive our success, and we're committed to attracting and retaining top talent.

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.

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 with a least one year of experience.
• 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.