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Sr. Quality Engineer; Contract Mfg; Supplier Quality

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Date: Oct 20, 2021

Location: Libertyville, IL, US

Company: Hollister Incorporated

We Make Life More Rewarding and Dignified

Location: Libertyville 
Department: Quality 

Summary:

Support the Global Contract manufacturing (GCM) virtual manufacturing facility in assuring quality products for Hollister’s customers.  This role includes operating as a core member (or leader) of project teams for new product development and change implementation. Evaluate and manage contract manufacturers, provide assistance by identifying quality improvement initiatives and cost savings.  Address quality concerns for current products, development opportunities, and process improvements that positively impact GCM product quality and the Hollister Quality Management System.  Partner with the cross-functional team members to achieve GCM and Global Quality objectives compatible with Hollister Mission and Vision.

 

Responsibilities:

  • Drive Supplier selection and evaluation process of new and existing Contract Manufacturers. Execute quality agreements, and perform audits of Contract Manufacturers as part of initial assessment and ongoing management of Supplier relationships; ensure compliance with relevant quality system regulations.
  • Act as primary quality contact with Contract Manufacturers, working with them to solve issues that arise and recommend improvements. 
  • Monitor supplier quality performance metrics and drive resulting corrective/preventive actions determined to be necessary 
  • Actively help maintain and improve a Quality System compliant with FDA regulations and ISO 13485 (e.g., training documents, procedures, work instructions, specifications, labeling)
  • Assist in any external regulatory audits (FDA, notified body) in support of the Hollister Quality Management System
  • Interface with internal functions, such as Design Assurance, Global Engineering, and R&D, on new product development projects and significant changes related to contract manufactured finished goods and processes. Support development and maintenance of Design History File (DHF) and Technical Files for Hollister-owned design and private label products.
  • Coordinate successful design transfer from Hollister to Contract Manufacturers, including Device Master Record (DMR). Support execution of Hollister projects within the scope of design controls, liaising between Hollister and the supplier. 
  • Utilize strong understanding of statistical analysis methods (ANOVA, Hypothesis testing, process capability analysis, DOE, GR&R, survival analysis, measurement system analysis, etc.) to ensure that manufacturing processes are appropriately qualified, and requirements are met prior to commercialization. 
  • Coordinate process validation, process control, and process capability studies where appropriate, to ensure that quality controls are maintained.
  • Contribute to or lead Risk Management activities for new or existing products, including but not limited to risk assessment, DFMEA, PFMEA
  • Review Device History Records (DHR) to support release of finished goods from Contract Manufacturers to distribution facilities
  • Identify and implement cost savings opportunities by partnering with Operations and Engineering
  • Mentor and train others on subject matters related to the certified quality engineering body of knowledge and contract manufacturing principles and practices
  • Develop specifications, bill of materials (BOM), and other documentation as needed. Coordinate, review and approve product and process changes.

 

Requirements:

  • Bachelor's degree is required; Engineering, Math, Physical Sciences, Computer Science or related study is preferred
  • Master’s Degree preferred
  • 8-12 years overall experience is required
  • Minimum of 5 years’ experience in a Quality Engineering (or equivalent industry discipline) required
  • Experience supporting new product design and interacting with supply base to assure successful outcomes (Design Controls) is required
  • Experience in Medical Device Manufacturing in compliance with applicable foreign and domestic regulations including US FDA 21 CFR Part 820, ISO 13485, EU Medical Device Regulation.
  • ASQ Certified Quality Engineer highly desired
  • Experience working in a virtual manufacturing plant environment with all products being manufactured by 3rd parties to owned and/or supplier's specifications.
  • Knowledge and experience in statistical software packages (ex. Minitab) for data analysis
  • Project management 
  • ASQ Certified Quality Auditor or Recognized Lead Auditor Certification Program
  • Basic technical writing skills required, advanced technical writing skills preferred
  • Knowledge of SAP/ERP Systems a plus
  • Ability to train / facilitate others inside and outside of the company
  • Good communication skills, both written and oral, to an international supply base with varied cultural expectations
  • Ability to travel domestically/internationally 20-30%

Hollister Incorporated is an independent, employee-owned company that develops,manufactures, and markets healthcare products worldwide. The company develops and manufactures products for ostomy care, continence care and critical care, and also develops educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, it 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 (JDS Inc), a 100 year old company. Hollister is guided by the shared Mission of JDS Inc, to make life more rewarding and dignified for people who use its products and services.  www.Hollister.com 

Hollister is an EO employer – M/F/Veteran/Disability


Job Req ID: 29537


Nearest Major Market: Chicago

Job Segment: Risk Management, ERP, Product Development, Supply, Computer Science, Finance, Technology, Research, Operations