Senior Quality Engineer (Validations)

Hollister Incorporated; Illinois; On-site; USD 80,000 - 100,000; Full time

Job summary

Hollister Incorporated is seeking a Senior Quality Engineer (Validation) to support Ostomy projects and ensure compliance in a regulated environment. The successful candidate will manage validation projects, mentor peers, and carry out statistical analyses within a dynamic team environment.

Qualifications

• 5-8 years overall experience or minimum 3 years in a similar role.
• Relevant experience in the medical device industry or equivalent regulated industry.

Responsibilities

• Manage multiple projects - Process and Equipment Validation including DV, FAT, IQ, OQ.
• Support Ostomy Compliance activities and quality improvements.
• Mentor and support Ostomy QEs through projects.

Skills

Statistical analysis

Quality Assurance

Process and Equipment Validation

Education

Degree in Engineering/Science Discipline

Quality Engineering Qualification or equivalent

Job description

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We Make Life More Rewarding and Dignified

Location: Ballina
Department: Quality

The primary purpose of the Senior QE (Validation) role is to support Ostomy projects and support any other QA activities on site as required. The primary customers include Ballina Engineering, Manufacturing, Supply Chain Management and Product Development.

Responsibilities:

• Manage multiple projects - Process and Equipment Validation including DV, FAT, IQ, OQ, PQ protocol development, implementation and report completion per timelines
• Support Ostomy Compliance activities and support quality improvements as required
• Completion of statistical analysis in compliance with Quality System requirements
• Leading and executing PFMEAs.
• Supporting Manufacturing for quality related matters when required
• Mentor and support Ostomy QEs through projects and ensure completion of projects per timelines
• Lead Ostomy projects and ensure completion of projects per timelines
• Work with the Validation Supervisor on team development activities.

Work Experience Requirements

• Number of Overall Years Necessary: 5-8 OR a minimum of 3 years’ experience in a similar role with a relevant level nine qualification
• Relevant experience in the medical device industry or equivalent regulated industry

Education Requirements:

• Degree in Engineering/Science Discipline required
• Quality Engineering Qualification or equivalent is desirable

Specialized Skills/Technical Knowledge:

• Knowledge of statistical analysis, ISO 13485 and FDA 21 CFR Regulations, Quality Assurance

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.

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