Plant Quality Engineer III

Hollister Incorporated; Stuarts Draft (VA); On-site; USD 65,000 - 115,000; Full time

Job summary

Hollister Incorporated in Stuarts Draft, VA is seeking a Quality Engineer to support change controls, CAPAs, QNs, process capability studies and related quality activities on the manufacturing floor.

Bachelor’s degree in engineering or related science; 0–5 years experience in quality engineering; familiarity with 21 CFR 820 and ISO 13485; knowledge of Minitab, SAP/ERP, and MS Office is preferred. ASQ CQE and lean Six Sigma knowledge are desirable.

Qualifications

• Bachelor’s degree in Science (Engineering, Math or related field).
• 0–5 years experience in quality engineering preferred.
• Experience with medical device QMS per 21 CFR 820/ISO 13485 preferred.
• ASQ CQE preferred.

Responsibilities

• Act as Quality Resource to help facilitate completion of assigned Change Controls.
• Lead and perform pFMEA and products/process qualifications.
• Review, evaluate and disposition non-conforming materials.
• Respond to assigned CAPAs and QNs for investigation, root cause analysis and implement solutions.
• Plan, coordinate, execute and document process capability, validation studies, and process improvement studies.
• Create, execute and conclude results for protocols, including final reports and summaries.
• Support Operations and GQM strategic plans in leading or supporting projects.
• Plan, coordinate, and document Quality Plans and work instructions.
• Conduct training on defect awareness.
• Work collaboratively with Value Stream Process Engineers to identify, investigate and solve quality issues.

Skills

Basic statistics

Minitab

Technical writing

Audits

Lean Six Sigma

Education

Bachelor's degree in Science/Engineering

Tools

SAP/ERP

Microsoft Office

Job description

We Make Life More Rewarding and Dignified

Location: Stuarts Draft

The salary range for this role is dependent on education & experience. $65,000-$115,000

Responsibilities:

• Act as Quality Resource to help facilitate completion of assigned Change Controls.
• Lead and perform pFMEA and products/process qualifications.
• Review, evaluate and disposition non-conforming materials.
• Respond to assigned CAPAs and QNs for investigation, root cause analysis and implement solutions.
• Plan, coordinate, execute and document process capability, validation studies, and process improvement studies.
• Create, execute and conclude results for protocols, including final reports and summaries.
• Support Operations and GQM strategic plans in leading or supporting projects.
• Plan, coordinate, and document Quality Plans and work instructions.
• Conduct training on defect awareness.
• Work collaboratively with Value Stream Process Engineers to identify, investigate and solve quality issues.
• Responsible for achieving competency in all identified skill requirements outlined in associated training profile for position.
• Other duties and tasks as assigned.

Essential Functions of the Role**:

• Prolonged periods of sitting
• Ability to interface with a computer for long periods of time
• Frequent movement over large manufacturing floor areas
• Occasionally move products/parts from production floor into testing area, up to 20 pounds
• Travel requirements
• Ability to train/facilitate
• Flexible work schedule with start/stop times across all shifts
• Communication skills, both written and oral

Work Experience Requirements

• Number of Overall Years Necessary: 0-5 years
• Experience in Quality Engineering or equivalent industry disciplines preferred
• Experience in medical device manufacturing regarding Quality System requirements per 21 CFR 820 and/or ISO 13485 preferred

Education Requirements

• Bachelor's Degree in Science (Engineering, Math, Natural Sciences, or related study preferred)

Specialized Skills/Technical Knowledge:

• Knowledge and application of basic statistics and experimental design preferred
• Knowledge and experience in statistical software packages preferred (ex. Minitab)
• Technical writing skill preferred.
• Experience working with self-directed work teams preferred
• Experience performing internal/external audits and evaluations preferred
• Experience with product design and product design related regulatory requirements preferred
• Knowledge and implementation of medical device Quality System requirements (FDA and ISO) preferred
• ASQ Certified Quality Engineer preferred
• Knowledge of Lean and Six Sigma Black Belt principles preferred
• Basic technical writing skills required, advanced technical writing skills preferred
• Knowledge of SAP/ERP Systems a plus
• Knowledge of Microsoft Office Products (Word, Excel, Project, Access, PowerPoint)

Local Specifications (English and Local Language):

• English

About Hollister Incorporated

Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.

EOE Statement

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job Req ID: 36490