Plant Quality Engineer

We Make Life More Rewarding and Dignified
Location: Stuarts Draft
Department:
Support the plant manufacturing facility in assuring quality products by meeting all regulatory compliance requirements of the Quality System, performing process capability studies, determining process improvements, instituting corrective action for process & Quality System deficiencies and partnering with operations in achieving both plant and GQM objectives compatible with Hollister's Mission and Vision.
SUMMARY:

• Serve as Quality Resource for new product development and sustaining engineering.
• Act as Quality Resource to help facilitate completion of assigned change controls.
• Lead and perform pFMEA and products/process qualifications for new product launches.
• 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.
• Assist Sr. Quality Engineers to perform Gage R&R studies and DOEs as needed.
• Support Operations and GQM strategic plans in leading or supporting projects.
• Lead and facilitate internal audits and assist in performing vendor audits.
• Plan, coordinate, and document Quality Plans and work instructions.
• Assist Sr. Quality Engineers to prepare test/inspection methods including the purchase recommendation of test equipment as needed.
• 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: 5-8
• Minimum of 5-8 years of experience in Quality Engineering or equivalent industry disciplines required
• Experience in medical device manufacturing regarding Quality System requirements per 21 CFR 820 and/or ISO 13485 preferred

Education Requirements:

• Bachelor's Degree in Engineering, Math, Natural Sciences, Computer Science, or related study required

Specialized Skills/Technical Knowledge:

• Knowledge and application of basic statistics and experimental design
• Knowledge and experience in statistical software packages preferred (ex. Minitab)
• Experience working with self-directed work teams preferred
• Experience performing internal/external audits and evaluations preferred
• Experience in microbiology and sterilization (gamma/EtO) processes preferred
• Experience with product design and product design related regulatory requirements preferred
• Technical knowledge in systematic injection molding techniques and film sealing preferred
• Knowledge and implementation of medical device Quality System requirements (FDA and ISO)
• ASQ Certified Quality Engineer
• ASQ Certified Quality Auditor or Recognized Lead Auditor Certification Program 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

** To comply with regulations by the American with Disabilities Act (ADA), the principal duties in job descriptions must be essential to the job. To identify essential functions, focus on the purpose and the result of the duties rather than the manner in which they are performed. The following definition applies: a job function is essential if removal of that function would fundamentally change the job.
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. Find out more at www.Hollister.com
Hollister is an EO employer - M/F/Veteran/Disability
Job Req ID: 32166