Quality Engineer III

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.

Responsible for daily tasks including quality checks on products, the use of multiple measuring tools, communication with leaders and team members, accurate documentation processes, internal audits, and customer audit preparation.

Education/Experience

• BS in Engineering required
• 8 + years' experience in quality engineering and/or
• 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 Precision Edge

• 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

Responsibility/Authority

• Develop and execute verification and validation plans associated with product/process quality according to ISO, FDA and Precision Edge procedures

• Create detailed and accurate project tasks and schedules, interfacing with internal and external customers and solving project related conflicts and issues

• Support supplier audits to ensure capability, including correlation of inspection methods, and evaluation of proposed supplier process changes to Precision Edge and customer requirements

• Support quality planning as necessary for product, including risk analysis for new and legacy products

• Perform hazard and risk analysis for new legacy products, including FMEA and decision tree analysis

• Act as liaison between QC personnel and operations personnel to ensure that inspection process capabilities have been verified and appropriately documented

• Lead root cause analysis for customer complaints and internal product quality issues

• Identify new inspection equipment to support production needs

• Authorized to approve product realization (Quality Control) documentation in the absence of the Manufacturing and Quality Engineering Manager or Quality Manager

• Develop and execute Measurement System Analysis

• Mentor and develop Quality Department personnel

• Train employees as needed

Supervisory Responsibilities

• Quality Engineer I, Quality Technician and/or Inspectors as designated by Quality Manager or Manufacturing and Quality Engineer Manager

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.