Plant Quality Engineer III

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.

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